Quality Engineer

Our Molex facility in Phoenix, AZ is currently seeking qualified candidates for the 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, and FDA regulatory requirements as well as supports the Production Quality functions to ensure that established level of product quality is maintained.

• Interface with Engineering, Manufacturing and Customer Service Groups
• Perform Supplier Evaluation by monitoring product quality
• Coordinate testing for quality of finished products as needed
• Review and approve Engineering Drawings and Manufacturing Instructions
• Coordinate periodic Gage R&R’s as needed
• Manage and coordinate the 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 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
• Review and Approve Cleanroom and Gowning Room Environmental records
• Oversee Sterilization Process Requalification, as well as request an internal review of the sterilization process by Sterilizer
• Support product and process validation

• Legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship
• Bachelor’s Degree in engineering or science
• Engineering experience in a manufacturing or industrial environment
• Experience in supplier quality management
• Experience with ISO 13485

• Experience in sterilization and complaint handling
• 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

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate s knowledge, skills, abilities, and geographic location.

If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here.

As a Koch company, Molex is a leading supplier of connectors and interconnect components, driving innovation in electronics and supporting industries from automotive to health care and consumer to data communications. The thousands of innovators who work for Molex have made us a global electronics leader. Our experienced people, groundbreaking products and leading-edge technologies help us deliver a wider array of solutions to more markets than ever before.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement,…