asq national news - files.meetup.comfiles.meetup.com/15843522/2015-10newsletter.pdffour brand new...
TRANSCRIPT
- 1 -
Next ASQ Boulder Section meeting is on Thurs, Oct 22nd at Display Devices Inc. located at former Rocky Flats Visitor Center. Doors open at 5:30pm More of meeting details and map on page 3.
Four brand new Oct ’15 job posting, See page 11.
Volume 22, Issue 7 October 2015
OCTOBER CHAIR MESSAGE Welcome to the 2015-2016 season for ASQ. I hope you all had a wonderful, fun-filled summer. As the weather turns cooler and as we look forward to the aspen turning colors in the next few weeks, the ASQ section meetings will be resuming. Your committee has been hard at work developing a meeting and education program for the year. It is a work in progress but I believe you’ll find it very interesting and educational – our plan is to maintain the alternating speaker/tour program as the year unfolds. To kick off the year, I’d like to introduce myself. I am a degreed Engineer and a Lean Six Sigma Black Belt (I’ve been told by many that getting my LSS certification was much like getting a Master’s degree – for those with Master’s degrees, I have a newfound respect!). I have worked in the manufacturing field for more than 35 years as a Quality Engineer, Production Engineer, and Continuous Improvement Manager, among other things. During this time I was a paying member of ASQ and was involved with the local sections, in one form or another. It has only been the last several years that I got involved with the leadership portion of the section. Why? I felt it was time to give back to the section what I had gained from its members and I felt I could help improve it in a small way. So why was I hesitant up until now? Time? Know-ledge? Expertise? I’m not sure When I finally joined the leadership ranks I found that we are all just folks with similar backgrounds and work interests trying to make our work lives better and feel ASQ has much to offer; ASQ wouldn’t exist if it wasn’t for its members. I also found that ASQ is also a great network if you are looking for new opportunities. Use it to your advantage! The section is here for its members (that’s you and me) and the leadership’s role is to guide these efforts. I encourage you to get involved in the section, even if it means offering suggestions for direction and improvement. Feel free to reach out to any of the committee or members if you have any questions, concerns, or opportunities for improvement. Remember, we are all in this together. Yours in service, Dan Clark
--------------------------------------------------------- We’ll have a Dec “Spouses Night” again at the Boulder Dinner Theater on Wed, Dec 16th. There will be 18 seats available on a “first come, first reserve and first pay basis per couple”. Details the same as previous years with 50% ticket subsidy from Section. Show is the Musical Comedy of the Addams Family. You can put in a RSVP as “a place holder”, effective now. One of the two in your party must be a paid-up ASQ and a Boulder Section Member. Contact Gerry Naugle (info on page 2) to make a RSVP. ASQ's Members and Customer Service Center:
E-MAIL: [email protected]
PHONE: 800-248-1946
FAX: 414-272-1734
USPS MAIL:
ASQ Communications 600 N. Plankinton Ave. P.O. Box 3005 Milwaukee, WI 53201-3005
We suggest that you go to the ASQ National website at: www.asq.org for complete ASQ national news, regional event(s) links, books, courses, yearly certification testing, re-certifications, conferences, ASQ Divisions and on-line membership forms, including member upgrades and what is needed to update your own member profile. And, while you are on the internet, be sure to visit the ASQ Boulder Section website at: http://asqBoulder.org
------------------------------------------------------------
ASQ National News
Keep Calm and Prepare for ISO 9001:2015
Revisions of ISO management systems are often accompanied by a bit of anxiety. More than 1 million organizations have been certified to ISO 9001:2008, the international quality management system (QMS) standard, and they now must embark on implementing a revised version to be published later. What are the key changes we must be aware of? When and how should we introduce the required changes? What resources will we need? Check at ASQ website, at: www.asq.org
ASQ National and Boulder Section News is continued on page 4 ASQ #1313 Officers & Committee Chairs 2015-16
- 2 -
ASQ Section 1313 Boulder, CO
Title: Chair Name: Dan Clark Phone: 720-326-8240 [email protected]
Title: Vice Chair Name: Arta Doci Phone: 720-256-6677 [email protected]
Title: Secretary Name: Patricia Fleenor Phone : 303-501-8457 [email protected]
Title: Treasurer Name: John Beachman Phone: 720-313-2746 [email protected]
Title: Re-Certification Name: Gerry Naugle Phone: 303-591-2830 [email protected]
Title: Internet & Website Name: Arnold Miller Phone: 303-466-2631 [email protected]
Title: Publicity and VOC Name: Byron Murray [email protected]
Title: Education Chair Name: Joe Wojniak Phone: 970-619-9395 [email protected]
Title: Financial Auditing Name: Ewald Schelert Phone: 303-702-9009 [email protected]
Title: Past Chair Name: Joe Wojniak Phone: 970-619-9395 [email protected]
Title: Newsletter Co-Editor Name: Gerry Naugle Phone: 303-591-2830 [email protected]
Title: Newsletter Co-Editor Name: Bill Dunford Phone 720-340-0454 [email protected]
Title: Certification Name: Nixion Mead Phone: 720-320-6395 [email protected]
Contents
Online Content Exclusively for Members:
Member Gift Bundles: Check at the ASQ Website
October 2015 Member Gift Bundle: ISO 9001:2015
Learn About Quality: ISO 9001:2015 (Web pages)
Learn About Quality: ISO 14001:2015 (Web pages)
ASQ TV Standards Channel
ISO 9001 Presentation and Meeting Kit
Transition Guidance Document from ISO 9001:2008 to
9001:2015
Download your gift today
Lean & Six Sigma Blended Learning Take Your Company Further
Whether you are starting or moving ahead with your Lean Process Improvements, our blended learning will be
valuable to your improvement processes. Our eLearning courses will provide you with online modules that will
blend with classroom instructor training. Here are some benefits of our Blended Learning Options:
24/7 email/phone assistance by one of our certified Master Black Belts Onsite training at any location
Customized training for specific industries. With over 100 modules available, we can customize your course to
meet your organization's specific needs including Lean modules that are available in Spanish. Here is a sample of
some popular standard courses: Lean Essentials Lean Essentials Healthcare Lean Six Sigma Yellow Belt Lean Six Sigma Green Belt Lean Six Sigma Black Belt Project Management
_
Lean Six Sigma Experts-LSSE 3609 Wadsworth Blvd. #380 Lakewood, CO 80235
(800) 961-9479
#1313 Upcoming Meeting Information Page 3
ASQ National & Boulder Section News Page 4
Re-cert Journal Information Page 4
Quality Press Page 5
Boulder Section Course Offerings Page 6
Section Course Registration Form Page 7
Non-ASQ Section Training Offerings Pages 8-10
Quality Related Careers Job Postings Page 10 - 13
RMPEx Events and Updates Page 14
- 3 -
Upcoming October ASQ Boulder Section Meeting Thurs, Oct 22nd Facility Tour of: Display Devices Inc, at: 10828 CO-Hwy 93, Golden,
CO 80403. (They are in the building which used to house the Rocky Flats visitor center)
located in the middle of the west side of the property. Their website
is http://www.displaydevices.com/. 5:15pm We suggest to arrive 15 minutes early to sign-in 5:30pm Snack-Food and Networking
6:05pm Welcome to section and announcements 6:15pm Presentation
Speaker: Facility Manager Topic: Tour of the facility (see Google Map, below) 7:30pm meeting over
---------------------------------------------------------------------------------------------------
RMPEx Rocky Mountain Performance Excellence Program (which is also the Colorado State Quality and Business Performance Program), please see articles starting on page 12 for most recent information of RMPEx activities and events. The Boulder ASQ Section is an active sponsor of the RMPEx Organization. http://rmpex.org/ RMRAS Rocky Mountain Regulatory Affairs Society http://rmras.org/ RMRAS is the premier local professional society in the Denver-front range area for individuals involved in medical devices or the pharmaceutical industries. Membership is free of charge. And, our societies’ recertification units (RUs) are reciprocal and interchangeable.
- 4 -
News continued from page 1
ASQ National – and – Local ASQ Sections’ News
BOULDER SECTION CORRESPONDENCE ADDRESS ASQ Boulder Section P.O. Box 3783 Boulder, CO 80307 The section website for much information and resources’ links is: http://asqBoulder.org
Note: All education & course registration materials should be sent to Section Education Chair (please see the last page of the education section for contact information).
Updates to ASQ Re-cert Journal & Cost-Increase for 2015
There are changes to the recertification journal categories, including more opportunities for RU credits, and categories have been better defined to make recertifying easier. The 18 RU credit amount each three years remains the same. The new journal can be downloaded and printed directly from the main ASQ National website at: www.asq.org using “Certification” / then the / Re-certification Link” or call ASQ Customer Care at: 1-800-248-1946 and request item B0525
The re-certification costs have recently increased due to higher costs to administer the program. Recertification by journal for members is now $69 for one certification (or) $89 for two or more certifications (e.g., if you get re-certified for two, three or more areas, you still only pay $89). Anyone starting a re-certification journal through ASQ Boulder Section is strongly urged to send an e-mail before you start to the Re-cert Chair, Gerry Naugle at: [email protected]. Abstract: there are deployed and effectively implemented policies & procedures which can save you some time, effort and USPS postage.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------
Boulder Section’s Current ASQ Fellows
Tripp Martin – Retired Edward Arling Liz Keim, ASQ Past-Pres.& Board Chair International Auto Oversight Bureau Quality Compliance Assoc. Integrated Quality Resources, LLC (248) 535-5670 (303) 579-9443 (303) 541-9127 [email protected] [email protected] [email protected]
Advertise in the ASQ Boulder Section e-newsletter in 2015-16!
Effectively get your company (or) organization’s information out in front of Boulder, Broomfield and Denver County QA Professionals.
Number of Issues ¼ Page ½ Page
One Issue (month) $20 $30
Eight Issues (year) $60 $80 Interested? Contact Gerry Naugle at: [email protected] (or) 303-591-2830
- 5 -
From ASQ Quality Press Order at: 800-248-1946 ASQ Quality Press books can be ordered online, or for special pricing on orders of 10 or more call ASQ Customer Care / Quality Press Bookstore at: 800-248-1946.
New Book! Quality Improvement Supports STEM Cindy P. Veenstra, Fernando F. Padró, and Julie A. Furst-Bowe In July 2011, the ASQ Education Division held its first STEM Agenda Conference. This publication is a selection of the conference papers and workshops from the conference, with the theme Advancing the STEM Agenda in Education, the Workplace, and Society. The book highlights STEM education as a grassroots effort by many educators to ultimately prepare graduates for the 21st century workforce.
New certification preparation book from ASQ Quality Press The Certified Six Sigma Master Black Belt Handbook
This book reflects the most current thinking among Six Sigma leaders who came together to create the ASQ Master Black Belt Body of Knowledge (BoK). The primary audience for this book is the individual who plans to prepare to sit for the Six Sigma Master Black Belt certification examination. The book is great for quick reference and ease of use because the chapter and section numbering exactly mirrors that of the Master Black Belt BoK
Best Practice in Team Excellence J.P. Russell, editing director This book explains the Team Excellence Framework (TEF) and how to leverage it to ensure the success of your improvement teams. This framework has a long-standing track record of providing the means by which teams can produce highly successful outcomes for their organizations.
Bestseller! The Certified Quality Engineer Handbook, Third Edition Connie M. Borror, editor This third edition provides the quality professional with an updated resource that exactly follows ASQ’s Certified Quality Engineer (CQE) Body of Knowledge.
Reliability Data Analysis with Excel and Minitab Kenneth S. Stephens When a product has been designed and manufactured, its performance in terms of durability, strength, and life become a matter of test, measurement, and analysis. This book helps you understand the outcomes of the reliability tests and translate that into real-world data that can improve products. Excel and Minitab spreadsheets are included for all sample data sets.
- 6 -
ASQ BOULDER SECTION #1313 COURSE DESCRIPTIONS INSTRUCTORS & COURSE DESCRIPTIONS: A list of instructor biographies and course descriptions can be
found on the ASQ Boulder Section web site, http://asqBoulder.org COURSES LOCATIONS: Contact the ASQ Boulder Education Chair, Joe Wojniak, (970) 619-9395 to see if the class you want can be made available in the Denver-North Loveland or Ft. Collins area.
2015 ASQ Boulder Section Course Offerings Updated 09-07-2015
Course Name Instructor Course Fee (1) (2) Exam
Date (3)
ASQ Exam
Application
Deadline
Course
Dates &
Times
Course
Registration
Deadline
1301 - Certified Quality Engineer (CQE) Review
Monrad Monsen 303-272-9612 Location: Contact Instructor
$400 members / $450 others
10/3/2015 3/5/2016
Past Deadline 1/15/2016
TBD TBD
1305 - Certified Software Quality Engineer (CSQE) Review
Arnold Miller 303-466-2631 Location: TBD
$400 members / $450 others
10/3/2015 3/5/2016
Past Deadline 1/15/2016
TBD TBD
1322 - ASQ Exam BoK: Quality Concepts, Management and Leadership
Ron Sedlock 303-716-5873 or 303-587-9153 Location: TBD
$270 per student + $25 material = $295 Total
10/3/2015 3/5/2016
Past Deadline 1/15/2016
TBD TBD
1323 - ASQ Exam BoK: Statistical Principles, Techniques and Applications
Ron Sedlock 303-716-5873 or 303-587-9153 Location: TBD
$270 per student + $25 material = $295 Total
10/3/2015 3/5/2016
Past Deadline 1/15/2016
TBD TBD
1324 - ASQ CQE Book of Knowledge (Bok) Review
Ron Sedlock 303-716-5873 or 303-587-9153 Location: TBD
$135 per student + $15 material = $150 Total
10/3/2015 3/5/2016
Past Deadline 1/15/2016
TBD TBD
(1) Course fee for ASQ or other professional society member/non-member. (2) Cost of primers, texts, work-books, etc. are not included and must be purchased by the student prior the first class. (3) See ASQ webpage for other certifications and test dates associated with conventions. http://asq.org/cert/dates (4) Contact the Boulder Education Chair, Joe Wojniak (970) 619-9395 http://asqBoulder.org courses If there is a class you
need but is not listed above. We may be able to offer that class in the future.
COURSE REGISTRATION INFORMATION You do not have to be a member of ASQ to attend a class however, members of ASQ and other professional societies receive a discount for classes. Local Quality professionals teach all classes in the Boulder/Longmont /Broomfield area unless otherwise noted. We contact you at least two weeks in advance of the class start date for the exact location. Classes are typically held at a company that employs one of the students. You may nominate your company for hosting a class. Directions and registration confirmations are provided. Participants receive a certificate upon completion of the course. We need a minimum of about 4 - 5 students to hold a course and we reserve the right to cancel or postpone classes not having enough students. A full refund will be given if minimum class registration requirements are not met. If you cancel within two weeks prior to a class beginning you may not receive a refund.
ASQ CERTIFICATION REVIEW COURSES: These courses are intended as a refresher course for those preparing to take the
ASQ Certification exam. These courses are typically not introductory and are intended for people with either academic and/or on the job experience. NOTE: Enrollment in a class DOES NOT enroll the student for the certification exam. The student is responsible for confirming exam dates and application deadlines with ASQ Headquarters. Qualification requirements for sitting for an exam and information regarding exam applications may be obtained by calling ASQ Headquarters at 1-800-248-1946 or go to http://www.asq.org
- 7 -
ASQ #1313 COURSE REGISTRATION FORM Please complete the following information as thoroughly as possible. In case of a schedule change or cancellation, we really appreciate two phone numbers to contact you. Student’s Name: ASQ Membership #: or other Society and #: Title of Course: Company Name: Address:
Daytime phone: Night time phone:
E-Mail: or FAX: Course # and Name: Course Start Date: Course Fee: $ (ASQ Member) $ (Non-member) Please enclose a check payable to “ASQ Boulder Section” and contact the Boulder Section Education Chair Joe Wojniak, (information on page 2) to reserve your spot in the course that you want. Please send checks to this address: ASQ Section 1313 Education c/o Gerry Naugle, P.O. Box 3783 Boulder, CO 80307 GUARANTEE: If you pay for and take one of our ASQ Certification review courses and still fail the Certification Exam, you may retake the course for free as many times as you need. The instructor reserves the right to charge for course materials (e.g., handouts, etc.). Your ASQ section leadership is committed to meeting your quality-related education and certification needs. If you have any questions about a particular course, please contact the instructor or the Boulder Section Education Chair (contact information above).
- 8 -
Non-ASQ Boulder Section (or) Non-ASQ Denver Section Training Resources
From: Ron Sedlock, the quality Catalyst
Hard to believe but it's the second half of 2015. Although my availability is somewhat limited for the rest of the
year, let me know if you have any training needs. If you are seeking ASQ certifications I do exam preparation
classes for most certifications. For the December exams such as:
Certified Quality Engineer (CQE)
Certified Quality Auditor (CQA)
Certified Six Sigma Green Belt (CSSGB) You should begin the exam preparation process no later than September. Also the following are a couple of my
most popular courses:
Statistics: Principles and Applications
Process-based Audits (ISO9001:2015)
In these tough economic times, I have given and will continue to give individuals advice on quality and exam
preparation. This is a free service. Let me know how I can help.
Ron Sedlock the quality Catalyst phone: 303.587.9153 www.thequalitycatalyst.com I am vitally concerned with your privacy on the internet and respect your right to refuse any other email distributions from me. I do limit my email announcements to typically 2 times a year. If you choose to discontinue these mailings, let me know. Your email address will be immediately removed from my database.
Cavendish Scott, Inc. Cavendish Scott is the Rocky Mountain Region’s primary ISO 9001 training, consulting and auditing organization. They have given many presentations and workshops to ASQ members. Cavendish Scott, Inc. is the only US organization to have IRCA Certified ISO 9001:2015 Lead Auditor and Transition Training available. ISO 9001:2015 Lead Auditor/IRCA ISO 9001:2015 Lead Auditor Training, Denver: IRCA training focuses on successfully learning the requirements of the new standard and new auditing techniques and skills. It demands an activity based learning environment – not death by PowerPoint. Learn the new standard and how it will be audited. Now is the time to make your plan and get your quality team registered for classes so they can fully understand the newest standard October 26 – 30, 2015 December 7 – 11, 2015 ISO 9001:2015 Transition Training: The first step in addressing ISO 9001:2015 and upgrading your certification is a comprehensive review of the standard. Cavendish Scott, Inc., is presenting a one day intensive workshop to do just that. You will understand the requirements of the standard, their application, how they will be audited and implementation approaches. Solutions systems, best practices, and implementation plans will be discussed to give
One Day ISO 9001:2015 Standard Review and Transition Training November 19, 2015, Denver, CO
- 9 -
Rocky Mountain Regulatory Affairs Society
presents
Process Validation for Medical Devices
Thursday, November 12, 2015 8:00 am – 5:00 pm
After the success of this class in 2014, we decided to hold it again in order to reach those people who
were unable to attend last year.
This one-day Process Validation workshop intends to help make process validation a useful activity, with payback and not just cost. The presenters believe value-added process validation requires cross-functional interactions and aim to foster discussion among attendees at various levels of
expertise, and in different positions within their firm’s organization chart.
The workshop will include information, discussion, and case studies based on the following questions: Why validate? When to verify?
Does design control impact process validation? How does validation and verification relate to risk?
What is needed to document validation? Can we justify the cost of process validation?
Speaker Bios
Neil Burris - CBA, RAC, RM (AAM) Neil Burris entered the medical device business in 1988, working for a manufacturer of implantable cardiac pacemakers. Mr. Burris’ various experiences in Quality Systems, Contamination Control, Clinical Data Management, and Sterilization Science combine to form a background particularly
suitable for understanding Regulatory Affairs for Medical Devices. He strives to aid in facilitating the legal sale of ethical, safe, and effective devices. He has previously served on standards writing committees for the Association for the Advancement of Medical Instrumentation (AAMI) and the
Institute for Environmental Sciences and Technology (IEST). He currently serves on the Steering Committee Rocky Mountain Regulatory Affairs Society, and earns a living via a successful
independent consulting practice. Neil Burris was formally educated at Colorado State University, and holds degrees Chemistry and Microbiology. He is a Certified Biomedical Auditor, Regulatory Affairs
Certified, and a Registered Microbiologist.
Adrian (Ade) Elfe - CQM/OE, ASQ Fellow Mr. Elfe serves as Principle Consultant of Elfe Consulting assisting organizations in meeting their
start up, validation, auditing, documentation, regulatory compliance, regulatory submissions, process improvement, lean improvement and quality system needs.
Adrian retired in July, 2007 as a Corporate Executive from the Spectranetics Corporation a medical device manufacturer, after seventeen years. He served as Vice President of Quality Assurance and
Regulatory Affairs as well as a corporate officer.
- 10 -
He has been responsible for quality, general management, regulatory system development, implementation and compliance. He has been responsible for Quality / Regulatory System planning and implementation for fourteen different spin off/startup businesses in three different FDA Districts - all which have been successful. He has over With over 40 years of experience in the medical device
Industry, he has worked in domestic and foreign regulatory compliance, microbiological QA, new product development, product introduction and manufacturing facilities start up, integration and relocation. He has a technical background in Electrical Engineering, Management Systems and
Manufacturing Technologies. He is a Certified Quality Manager.
Location: University of Phoenix - Westminster
8700 Turnpike Drive
Westminster, CO 80031
Phone: 303-379-8600 303-379-8600
Turn onto Turnpike Drive off of Sheridan. The building will be on your left and the entrance is on the north side.
Cost:
Early bird registration until October 22, 2015 $345.00
Regular registration after October 22 $395.00
Continental breakfast, lunch and course materials are included in the cost.
Quality-Related Career Openings / New Job Postings Several QA/QE Positions Open at Zimmer Biomet Corp Broomfield/Interlocken
Quality positions are available at Zimmer Biomet Inc. Please apply at http://www.zimmer.com/careers.html 310 Interlocken Parkway, Suite 120 Broomfield, CO 80021 www.zimmerbiomet.com
6 Month Contract QE Opportunity in Littleton, CO. Job Description:
Utilize quality science techniques to effect continuous performance improvement at assigned suppliers; Reviews, analyzes, and reports on quality discrepancies related to process, assembly, manufacturing,
mechanical, electrical, hydraulic, or electro-mechanical systems; Ensure that performance and quality of products conform to established company and regulatory standards; Use surveillance and auditing techniques to identify opportunities for process and product improvement; Interfaces with manufacturing, engineering, customer, supplier, and procurement (as appropriate) to ensure
requirements / expectations are satisfied; Facilitate development of supplier recovery plans; Monitor and evaluate supplier process for compliance to purchase order and engineering requirements; Collaborate with supplier to investigate root cause and corrective actions when process or product deficiencies
are detected; Identify, plan, and facilitate cross-functional improvement activities;
- 11 -
Deploy variation management tools and techniques at select suppliers to mitigate risk; Regional travel is required within a 3 state area that may require overnight stays.
Basic Qualifications: Understanding of AS9100, AS9103, AS9110, and AS9120 standards; Working knowledge of Lean Six Sigma methodologies; Supplier quality management experience; Exceptional verbal and written communication; Cause Mapping; Surveillance and Auditing; Blueprint reading;
GD&T; Aircraft Systems and Structure manufacturing; Able to quickly assimilate web-based applications / databases; Self-starter with ability to manage workload with
minimal direction; Provide technical solutions to wide range of difficult problems; Proficient in Microsoft Office Suite.
Contact: Khorry Lewis, Verify, Inc. 2525 Main Street, Ste. 100 Irvine, CA 92614 Direct: 949-333-6518 FAX: 949-833-3913 E-Mail: [email protected] Web: www.vscnet.com
Sorin Group QA Manager At the heart of medical technology Sorin Group’s products improve health and the quality of life of more than 1 million patients in 100 countries every year. To deliver on our commitments to patients and healthcare providers, Sorin Group teams continue to research, develop, and deliver reliable and state-of-the-art therapeutic solutions that address unmet cardiovascular needs and improve patient outcomes. At Sorin Group, we are proud that our products help people all over the world live better day after day. Please submit your application to Meredith Wheeler ([email protected]). Job Title: Manager Commercial Quality Assurance Reports To: Director, Quality Assurance Position Summary: Under limited supervision, performs complex quality work of a broad nature to achieve successful outcomes of departmental and company objectives. Applies knowledge of regulations, standards, principles, theories, and concepts to ensure compliance in Company’s quality system procedures and processes. Successfully demonstrates an in-depth or breadth of quality/regulatory skill(s) that can be applied to company’s quality system restructure using a considerable amount of judgment and originality. Has broad and in-depth understanding of the Company’s practices, policies, and therapies, and uses the knowledge effectively. This position is the Company’s expert on documentation and quality systems. Management sees this person being responsible for daily compliance of quality system documentation in the Company. Essential Job Functions: • Develop budget and manage expenses for areas of responsibility. • Develop employees through performance management, including training plans. • Participate in efforts to develop and/or obtain the necessary tools to manage quality data and streamline processes. • Represent the company with regulatory agencies on project matters or during external audits. • Support internal and external audits and execute the appropriate actions for assigned audit findings. • Support implementation, investigation and closure CAPA projects. • Manage all activities associated with US Product Recalls and Field Corrections. • Manage all aspects of US product complaint handling and provide necessary international complaint handling support
within the BU. • Manage customer complaint letter program. • Provide product complaint and vigilance report trending for CAPA reviews. • Identify and lead departmental programs to improve productivity, quality, customer service, costs, etc. • Participate in and lead cross-functional teams to identify opportunities for quality and process improvements. • Perform other related duties as required in support of company and departmental objectives. • Develop and maintain risk analysis processes for US manufactured products.
- 12 -
• Manages Commercial Quality Assurance program and manages complaint investigations in the laboratory • Lead process to fulfill relevant FDA and international regulatory requirements. • Manage the US and International Med-Watch reporting program and provide technical support for Vigilance
reporting. • Participate in Management Reviews providing metrics and analysis to assess the adequacy and performance of the
Quality System. Knowledge, Skills and Abilities Required: • Demonstrates initiative and sound judgment • Demonstrates strong problem solving skills • Ability to work in a team environment • Ability to write and verbally communicate effectively • Demonstrate working knowledge of health and safety and biohazardous materials regulations • Ability to pursue, analyze, troubleshoot, and solve complex problems with simple solutions in a timely manner • Proficient in experimental design and data analysis techniques, including performing statistical analysis where
required • Possesses written and verbal technical communication skills for report writing, scientific and technical presentations • Ability to provide direct supervision of project teams and personnel as required • Knowledge of FDA and ISO quality system requirements • Project management and statistical analysis skills required • Demonstrated interpersonal and leadership skills and the ability to interact with diplomacy and tact while
maintaining appropriate assertiveness and persistence • Experience in budgeting and annual planning responsibilities • Repetitive work –computer keyboard, pinching, pulling, gripping, grasping • Oral and written comprehension/Mathematical Reasoning • Work with hazards – human and bovine blood, chemical reagents • Sitting and/or standing 50%
----------------------------------------------------------------------------------------
Terumo BCT CER Specialist The Clinical Evaluation Reporting Specialist is responsible for writing Clinical Evaluation Reports (CERs) for Terumo BCT products. The Specialist relies on clinical data, published literature, complaints, and adverse event reporting to create the CERs. A number of personnel from different departments will contribute documentation necessary for completion of a CER. The Specialist brings these individuals together and directs them regarding the information needed for CERs. The Specialist will be responsible for the final compilation/authoring of new CERs and annual CER updates. ESSENTIAL DUTIES AND RESPONSIBILITIES
e.g., Quality Assurance, Regulatory Affairs, Clinical Affairs, Clinical Research Scientists, Pre-clinical Research Scientists, and literature search representatives [e.g. Terumo BCT librarians]) to identify relevant documentation needed for the content of CERs.
iterature searches on Terumo BCT products and product families, and identified predicate and competitor products
-lane collaboration to 1) understand regulatory submissions and priorities, 2) compile product complaints for both
equipment and disposables, 3) conduct Adverse Event Reporting searches on Terumo products and product families and identified predicate and competitor products, and 4) compile clinical data, including Clinical Investigation Protocols and Clinical Study Reports, for Clinical Investigations
research priorities
approval of the CER
- 13 -
-clinical Scientist on relevant cross-functional teams to provide input on risk management deliverables, clinical research and literature evidence for product development process needs
OTHER DUTIES AND RESPONSIBILITIES
untries
inate findings quantified in the update process of Clinical Evaluation Reports
standards, good business practices and company documented procedures MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor’s degree in biological or medical science is required or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered
Experience
device/pharmaceutical industry in clinical or regulatory roles ence and understanding of clinical research and regulatory guidelines
Skills
l direction or supervision as well as function effectively as a part of a multi-disciplinary team
sciplines and functions related to CER content
-depth knowledge of regulatory process (CE Marking, IDE, PMA, 510(k), post-market/post approval), GCP
procedures, and legal compliance for pharmaceutical and/or medical device industry soft Office, Excel, Word, PowerPoint, Access)
PHYSICAL REQUIREMENTS Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. For more information about Terumo BCT, visit our website www.terumobct.com/careers. Join Terumo BCT as we unlock the potential of blood. We are the world leader in blood component technology, delivering products, services and solutions for customers and their patients worldwide. Through collaboration with our customers and a commitment to innovation, we are the only company with the unique combination of apheresis, manual and automated whole blood processing and pathogen reduction technologies coupled with robust technology, innovation and core competencies in therapeutic apheresis, cell collections and cell processing. As the largest medical device manufacturing company headquartered in Colorado our Global Company with regional headquarters in Brussels, Buenos Aires, Hong Kong and Tokyo our products are in use in more than 125 countries and territories with more than 5,200 associates around the world and 3,000 located in the U.S.
- 14 -
Our company has almost $1B in annual revenues and has been voted and recognized as:
talent development. (2011 & 2012) Denver Business Journal (2014 & 2015)
Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015 Our award-winning culture embraces:
eading technology through innovation and R&D
Click Here to see what our associates have to say about our culture. Each associate has a positive impact on our future by:
If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.
To apply, please go to: www.terumobct.com and apply for requisition NH-2845
-------------------------------------------------------------------------------------------------
Rocky Mountain Performance Excellence P.O. Box 17545 Denver, CO 80217
Phone 303-893-2739 http://rmpex.org/
Kim Griffiths, Executive Director: [email protected] Jim Walker, Award Program Director: [email protected]