QA/QC Manager Job Reference: QAMGR Location: Carlsbad, CA Posted: October 2018 Weekly Hours: 40

The Role At DNA Electronics, we are integrating cutting-edge semiconductor technologies with novel biochemical techniques to develop products for DNA analysis and molecular diagnostics. You will be working in the Quality department of a multi-discipline company and will ensure the management of the Quality Management System.

Responsibilities You will manage the QA department by performing and supervising the following activities:

• Review and approve internal documents as a representative of Quality Assurance • Manage all internal Quality audit activities • Maintain compliance with FDA and ISO requirements including the facilitation of FDA and

ISO audits • Utilize and maintain basic understanding of US and Global regulations for medical device

products. • Assist with the creation of documents that describe the company's procedures for

activities and processes related to its products and in accordance to requirements of ISO 13485:2016, 21CFR 820 QMS.

• Manage the evolving internal quality documentation system, provide compliance oversight to applicable internal activities, and maintain internal documentation processing functions and organizational records management.

• Be responsible for document and record control process as well as custody and archiving of the company's documents

• Provide timely feedback to management on product quality and schedule and lead Quality Management Reviews as required by the Quality System.

• Participate as an active team member and provide quality assurance advice to project teams to ensure product compliance as required.

• Process internal controlled documents including but not limited to: SOPs, forms, templates, internal reports, engineering documents, etc.

• Identify gaps in the current quality systems and propose viable solutions for improvement.

• Maintain and track internal training program • Support routine activities including change assessments, review of specifications, and

validation protocols. • Responsible for tracking non-conformances, CAPA and Complaint Handling. • Responsible for product surveillance and field actions.

You will also manage the QC department in the following activities:

• Incoming inspection and testing of materials, parts, and products to ensure adherence to established quality standards.

• Establish QC processes / method development with R&D • Devise and reviewing specifications for products or processes • Develop and analyze statistical data and product specifications to determine standards

and to establish quality and reliability expectancy of finished products • Set requirements for raw material or intermediate products for suppliers and monitor

their compliance • Provide technical and statistical expertise to teams • Formulate, document and maintain quality control standards and on-going quality control

objectives • Recommend new or improved quality control methods, procedures, and/or standards • Coordinate objectives with production procedures in cooperation with manufacturing to

maximize product reliability and minimize costs • Create, document and implement inspection criteria and procedures • Provide, and oversee, inspection activity for product throughout production cycle • Apply total quality management tools and approaches to analytical and reporting

processes • Interact with vendors to ensure quality of all purchased parts • Review and approve Contractor and sub- contractor quality control documentation to

ensure their planned activities meet contractual requirements • Create and direct environmental test functions and applications

• Maintain active role on internal continuous improvement teams • Propose corrective actions to improve compliance with quality specifications • Design, develop and implement quality control training programs • Investigate (and correct) customer issues and complaints relating to quality • Other duties as assigned

Qualifications & Experience A Bachelor’s Degree in a scientific discipline or working equivalent and 5+ years of Quality Assurance and Quality Control in the medical device, biological, or biotech industry is required. A minimum of 3 years’ management experience is also required.

• Ability to design and implements policies and procedures to ensure that quality standards are met

• The ability to work independently, show initiative, and be a solid team player • An excellent communicator capable of working collaboratively with colleagues in all

functions and at all levels • Exceptional verbal, written and organizational skills, excellent interpersonal and

communication skills, and the ability to work effectively in a fast-paced, start-up environment

• Must be able to write SOPs and other controlled documents • Must have strong computer skills; MS Office Suite • Analytical, logical thought process and meticulous attention to detail • Experience with establishing statistical techniques and analyzing statistical data

Apply

If you believe you meet the above criteria and would relish playing a key role in developing a revolutionary technology, we would be delighted to hear from you.

We offer a competitive compensation package to successful candidates.

Please email your resume and cover letter to: HR-US@dnae.com quoting

Your name and the job title in the subject line.

For more information about DNAe, please visit our website www.dnae.com