Quality Engineer

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.