About this position
Position Overview
TriMed is seeking a Quality Engineer I to support the quality and compliance of our medical device products and manufacturing processes. In this entry-level role, you will work under the guidance of senior quality engineers to support investigations, maintain the Quality Management System (QMS), and contribute to continuous improvement initiatives.
This position is ideal for an early-career engineer who is eager to build hands-on experience in a regulated medical device environment.
What You’ll Do
Support and maintain the QMS in compliance with FDA 21 CFR Part 820, ISO 13485, and internal procedures
Assist with nonconformance, deviation, and complaint investigations
Help draft and track CAPAs under senior guidance
Support new product development activities, including design reviews and V&V support
Provide quality engineering support to Manufacturing and Operations
Review and approve Device History Records (DHRs), batch records, and inspection results
Assist with 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 validation activities (IQ/OQ/PQ) for processes, equipment, and software
Analyze quality data and support continuous improvement projects
Track and report quality metrics (KPIs)
Cross-train as backup support for document control, training management, complaints, and GUDID activities
Required Qualifications
Bachelor’s degree in Engineering or a related technical field (or equivalent experience)
1–3 years of related experience (internships and co-ops may be considered)
Basic knowledge of FDA 21 CFR Part 820 and/or ISO 13485
Strong analytical and problem-solving skills
Ability to work independently and cross-functionally
Strong written and verbal communication skills
Preferred Qualifications
Medical device or other regulated manufacturing experience
Exposure to CAPA, NCR, or complaint handling processes
Familiarity with root cause tools (5 Whys, Fishbone, basic FMEA)
Working knowledge of SPC, MSA, or statistical methods
Experience with quality software (Minitab, JMP)
Basic knowledge of inspection techniques and document control
Travel & Work Environment
Approximately 20% travel
On-site role in Valencia, CA
Relocation assistance is not available for this position
Office and manufacturing environment
Ability to occasionally lift up to 25 pounds with or without reasonable accommodation
Why Join TriMed
At TriMed, you’ll gain hands-on experience in a regulated medical device environment while working alongside experienced quality professionals. We value collaboration, continuous improvement, and professional development.
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.
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