Manager, Quality Engineer - Contract

Scope of the Role

As Manager, Quality Engineer (Contract), you’ll lead quality engineering execution and provide hands-on technical direction to support compliance, risk remediation, new product development, and operational effectiveness. This onsite role in San Diego (5751 Copley Drive) is designed to strengthen product safety, reliability, and documentation rigor across programs.

Key responsibilities include leading and coaching Quality Engineers; driving risk-based problem solving and continuous improvement; supporting design and sustaining activities to applicable quality/regulatory standards; overseeing investigations and CAPA; partnering with suppliers on critical issues (including occasional onsite support); and developing/approving validation and test activities (IQ/OQ/PQ, method qualification/validation, gauge R&R, calibration procedures, and statistically sound sampling plans). You’ll also review/approve controlled documents and contribute to Management Review inputs.

Required qualifications:

• BS in an engineering discipline
• 5–7+ years in medical devices or similarly regulated ISO/cGMP/GLP environments
• Catheter/medical device experience; interventional cardiology helpful
• Complaint/CAPA investigation experience; strong statistics (DOE/Six Sigma) and root-cause skills
• Validation/compliance track record (e-beam sterilization and software validation preferred)

Apply to be considered for this contract opportunity.

How Your Days Flow

You’ll start onsite by aligning priorities with cross-functional partners, then shift between focused desk work and quick, in-person touchpoints with engineers and operations. Expect time in documents and data—reviewing technical reports, checking traceability, and ensuring controlled records are ready for review. Midday often includes short working sessions to unblock decisions, followed by time to shape clear recommendations for stakeholders.

As the day progresses, you’ll balance mentoring conversations with crisp status updates, keeping communication practical and action-oriented. When supplier or product issues arise, you’ll coordinate next steps and confirm timelines, closing out the day by organizing deliverables for upcoming reviews and keeping the team’s quality metrics moving in the right direction.