Title : Quality Engineer
Location: Tempe, Arizona
Experience: 3 5+ years
Industry: Medical Device
Position Summary
We are seeking an experienced Quality Engineer to support quality assurance and manufacturing activities within a regulated medical device environment. The role will focus on maintaining product and process quality, investigating nonconformances, supporting CAPA activities, and ensuring compliance with applicable quality system requirements.
Key Responsibilities
- Support day-to-day quality engineering activities for medical device manufacturing.
- Investigate nonconformances, deviations, complaints, and quality issues and perform root cause analysis.
- Lead or support CAPA, NCR, SCAR, and corrective action activities.
- Develop and maintain quality procedures, work instructions, inspection plans, and related documentation.
- Support process validation, equipment qualification, and process improvement activities.
- Perform risk assessments and support product/process changes through change control.
- Analyze quality data and identify trends and opportunities for improvement.
- Support internal, supplier, and regulatory audits as required.
- Partner with Manufacturing, Engineering, R&D, Regulatory, and Operations teams to resolve quality issues.
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable company quality procedures.
Required Qualifications
- Bachelor s degree in Engineering, Science, Quality, or a related technical field.
- 3 5+ years of Quality Engineering experience in the medical device industry.
- Strong experience with CAPA, NCR, Root Cause Analysis, and nonconformance investigations.
- Working knowledge of ISO 13485 and FDA Quality System requirements.
- Experience with risk management and quality documentation.
- Strong analytical, problem-solving, and technical writing skills.
- Ability to work effectively in a cross-functional, regulated manufacturing environment.