Quality Engineer

Our Phillips Medisize facility in Phoenix, AZ is currently seeking qualified candidates for our Quality Engineer position. The Quality Engineer maintains 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, & FDA regulatory requirements as well as supports the Production Quality functions to ensure that established level of product quality is maintained. Responsibilities Interface with Engineering, Manufacturing and Customer Service Groups Review and approve Engineering Drawings and Manufacturing Instructions Manage and coordinate the investigation of customer complaints Respond to customer issues in a timely and professional manner 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 that the resulting processes and products comply with the applicable requirements of 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 Qualifications Bachelor’s Degree in engineering or science Two (2) years or more engineering experience in a manufacturing or industrial environment Experience in supplier quality management Experience with ISO 13485 OR ISO 9001 Preferred Qualifications 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 Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter. Equal Opportunity Employer, including disability and protected veteran status. The employer uses E-Verify. #J-18808-Ljbffr Phillips Medisize