Quality Engineer I (QE I)

Location: Valencia, CA (On-site, Monday-Friday)
Department: Quality
Employment Type: Full Time

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.

• 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

• Bachelor's degree in Engineering or 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 effectively in cross-functional teams

• Strong written and verbal communication skills

• 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

• Approximately 20% travel

• On-site role in Valencia, CA

• Office and manufacturing environment

• Ability to occasionally lift up to 25 pounds with or without reasonable accommodation

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