Job Title: Manufacturing Quality Engineer
Location: San Diego, CA
Duration: 12 Months
Purpose of the role:
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
What You’ll Work On:
- Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.
- Support Test and Inspection Method development including Method Validation activities.
- Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
- Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
- Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
- Own Corrective Action/Preventive Action (CAPA) investigations.
Required Qualifications:
- Bachelor’s degree within an Engineering field or a closely related discipline.
- 0-4+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.
Preferred Qualifications:
- Bachelor’s or advanced degree in Mechanical or Biomedical Engineering
- Prior experience with Cardiovascular & Catheter medical devices
- Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
