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Senior Quality Engineer (IVD Device) - 10477

TalentZok San Diego, CA
  • Expired: 11 days ago. Applications are no longer accepted.

Senior Quality Engineer (IVD Device) - TalentZok


Are you looking for a new SQE career opportunity with an exciting clinical and diagnostic life science detection company that’s creating the new standard of merging silicon biosensor technology and established biological techniques that provides rapid diagnostic testing solutions for doctors, patients, and researchers?! THEN READ ON! In this role, you’ll support establishment of and maintain appropriate Quality Management System (QMS) consistent with ISO 13485:2016 and cGMP (QSR 21 CFR part 820) in a start-up environment! The resultant QMS must address the needs of design control, GMP manufacture, software and reagent test kits for in vitro diagnostic device. Ultimately the QMS needs to support ISO 13485:2016 certification and surveillance audits along with appropriate FDA QSR requirements. Interested? LET’S TALK!

Immediate opening for a Senior Quality Engineer in San Diego, CA who possesses:

  • Bachelor’s degree in chemistry, biochemistry, microbiology, engineering, or a related discipline.

  • 5 - 7 years related quality experience in an ISO 13485 and cGMP in an FDA regulated environment, in the medical device, diagnostics, pharmaceutical, or biologics field.

  • Previous experience with the investigation of quality events (deviations, non-conformances) and the management of CAPA systems to demonstrate effective resolution and create concise reports.

  • Advanced knowledge of design control, software and hardware verification and validation, change control, and quality controls. Familiar with design review processes, and capable to perform risk analysis and develop risk mitigation plans.

Email resumes to and call 858.356.6772


  • Ongoing Evaluation and maintaining Quality Assurance programs and systems starting from the Quality Manual through all levels of procedures to support an ISO 13485:2016 certified QMS.

  • Manage quality events to company goals including Nonconforming Materials, Deviations, Corrective and Preventive Actions and Customer Complaints to ensure product quality.

  • Work with Manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, testing is conducted, and that products, materials and manufacturing equipment meet required standards per appropriate regulations, guidance and external standards.

  • Perform statistical analysis to analyze trends, work with Engineering and Manufacturing to investigate trends, and conduct root cause analysis for processes and products manufactured externally or internally.

  • Write, review and/or approve validation protocols for all levels and areas of the QMS in compliance with ISO 13485:2016 and/or cGMP (21 CFR part 820) requirements.

  • Represent the QMS in communications with vendors, customers and auditors.

For immediate and confidential consideration, please email your resume to and call 858.356.6772

More information can be found at


IT'S ALL WE DO. We believe that effective and successful recruiting must be specialized, both in industry and geography. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. THE INSIDER'S NETWORK When you register with us, we plug you into an existing network of companies that don’t always post to job boards. You will have access to unique opportunities throughout the greater San Diego area - opportunities you won’t find on your own. THANK YOU FOR CALLING We’ve picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? How many recruiting firms have you sent your resume to who haven’t called you back promptly? At TalentZök, customer service is our priority. We return calls promptly. We don’t let you fall through the cracks. It sounds so simple yet so few know how to do it right. THE IMPORTANCE OF A FIRM HANDSHAKE There is no substitute for meeting someone in person. It is the only way to really understand people. We interview all of our candidates in person before they interview at our client companies to ensure the best possible fit. We also visit companies in person, meet the people involved in the decision, get a feel for the company culture and get a thorough understanding of the job. We won’t waste your time because we’re committed to understanding exactly what it is you’re looking for.


San Diego, CA