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 mturner@TalentZok.com 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 mturner@TalentZok.com and call 858.356.6772
More information can be found at www.TalentZok.com