Senior Quality Engineer - Medical Device Manufacturing at Jobot
Monrovia, CA 91016
About the Job
ON Site in Monrovia, CA - FDA QC Quality w. CQE
This Jobot Job is hosted by: Katherine Opie
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $110,000 - $120,000 per year
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
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
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
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Katherine Opie
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $110,000 - $120,000 per year
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
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
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
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
110,000 - 120,000 /year