Senior Quality Engineer ISO 13485
- $110,000 - $120,000
- Monrovia, CA
ON Site in Monrovia, CA - FDA QC Quality w. CQE
A bit about us:
Work for a stable and growing Medical Device Manufacturer in SoCal! This is an on site position.
Why join us?
Growth potential!
Work with a great team...
Competitive Pay and Benefits
Work with a great team...
Competitive Pay and Benefits
Job Details
The QC Quality Engineer supports process quality and testing improvement activities across engineering and is responsible for coordinating GMP activities to ensure that batches are tested and released to meet project timelines.
Sample Duties:
Investigate manufacturing nonconformance’s, product or component failures, customer complaints, or product returns by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA. Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.
Support supplier qualification activities and SCRs with appropriate departments.
Support regulatory filings including NDA, annual reports, and other documents for filings.
Provide guidance and leadership on design process characterization studies (DOE, R&R); conduct statistical analysis of results to identify critical parameters and improves process capability.
Experience, Education & Certifications:
Bachelor’s degree, preferably in Engineering or Sciences
5+ years experience in validation and/or quality engineering, ideally for ISO 14835
Advanced degree preferred.
Certified Quality Engineer (CQE) or equivalent preferred
General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization
Technical Writing & Reporting for compliance and/or validation/quality assurance
Sample Duties:
Investigate manufacturing nonconformance’s, product or component failures, customer complaints, or product returns by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA. Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.
Support supplier qualification activities and SCRs with appropriate departments.
Support regulatory filings including NDA, annual reports, and other documents for filings.
Provide guidance and leadership on design process characterization studies (DOE, R&R); conduct statistical analysis of results to identify critical parameters and improves process capability.
Experience, Education & Certifications:
Bachelor’s degree, preferably in Engineering or Sciences
5+ years experience in validation and/or quality engineering, ideally for ISO 14835
Advanced degree preferred.
Certified Quality Engineer (CQE) or equivalent preferred
General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization
Technical Writing & Reporting for compliance and/or validation/quality assurance
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.