Quality Engineer

Our Phillips Medisize facility in Phoenix, AZ is currently seeking qualified candidates for a Quality Engineer position. The Role is responsible for maintaining the Polymicro Quality Management Systems by developing, implementing, and improving the Quality System to satisfy both internal and external customers, while maintaining compliance with ISO 9001, ISO 13485, and FDA regulatory requirements. The Engineer supports Production Quality functions to ensure the established level of product quality is maintained. What You Will Do Interface with Engineering, Manufacturing and Customer Service groups Review and approve Engineering drawings and manufacturing instructions Manage and coordinate investigation of customer complaints Respond to customer issues in a timely and professional manner Lead root cause investigation projects Interface with customer and third‑party auditors to satisfy program requirements of ISO 9001 and ISO 13485 Author and update work instructions and documents to ensure compliance with ISO 9001, ISO 13485, 21 CFR 820, EU MDR, and current Good Manufacturing Practices Monitor and report product/process performance metrics to management on a quarterly basis Develop, implement, and maintain department work instructions Actively support Lean/Six Sigma initiatives and programs Support product and process validation Basic Qualifications Bachelor’s degree in engineering or science Two (2) or more years of engineering experience in a manufacturing or industrial environment Experience in supplier quality management Experience with ISO 13485 or ISO 9001 What Will Put You Ahead Experience with specialty optical fibers or fiber optic assemblies Working knowledge of FDA and 21 CFR 820 US Code Quality System requirements Knowledge of SAP Benefits Our benefits plan includes medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability benefits, retirement plans, paid vacation and time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Eligibility criteria are set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions about which benefits apply to you, please speak to your recruiter. Equal Opportunities Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, offers of employment may be conditioned upon successfully passing a drug test. This employer uses E‑Verify. #J-18808-Ljbffr