About this position
Position Overview
TriMed is seeking a Quality Engineer II to support the quality and compliance of our medical device products and manufacturing processes. In this mid-level role, you will independently lead investigations, support new product development, and partner cross-functionally to drive continuous improvement across the Quality Management System (QMS).
This position is ideal for a hands-on quality engineer who thrives in a regulated medical device environment and enjoys balancing compliance, problem-solving, and cross-functional collaboration.
What You’ll Do
Independently support and maintain the QMS in compliance with FDA 21 CFR Part 820, ISO 13485, and internal procedures
Lead nonconformance investigations and CAPAs, ensuring timely and effective root cause resolution
Provide quality engineering support for new product development, including design reviews, design transfer, and V&V activities
Partner with Manufacturing and Operations to resolve production quality issues and drive process improvements
Review and approve Device History Records (DHRs), batch records, and inspection results
Lead Material Review Board (MRB) activities and disposition of nonconforming material
Support risk management activities in accordance with ISO 14971
Participate in internal, supplier, and regulatory audits; support audit readiness and responses
Perform statistical analysis and trend quality data to identify improvement opportunities
Support validation activities (IQ/OQ/PQ) for processes, equipment, and software
Collaborate with Supplier Quality on supplier performance and corrective actions
Mentor junior quality staff and support continuous improvement initiatives
Required Qualifications
Bachelor’s degree in Engineering or a related technical field (or equivalent experience)
3–5 years of quality engineering experience in medical devices or regulated manufacturing
Working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
Experience with CAPA, nonconformance investigations, and root cause analysis tools (5 Whys, Fishbone, FMEA)
Experience supporting design controls and/or manufacturing quality
Strong analytical and problem-solving skills
Ability to work independently and cross-functionally
Preferred Qualifications
Experience with PPAP and APQP
Experience leading moderate NPI quality projects
Lean or Six Sigma training or certification
Experience supporting supplier quality activities
Advanced statistical analysis experience
Travel & Work Environment
Approximately 20% travel
On-site role in Valencia, CA
Relocation assistance is not available for this position
Office environment
Why Join TriMed
At TriMed, you’ll work on meaningful medical device products in a collaborative, quality-driven environment. We value continuous improvement, cross-functional partnership, and professional growth.
Benefits may include:
Medical, dental, and vision insurance
401(k) with company match
Paid time off and holidays
Professional development opportunities
TriMed, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Salary Information