Quality Engineer - Phillips-Medisize

Our Molex 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.

Our Team

Molex is a global team of innovators who design and create solutions for businesses where data, technology and the complex electronic solutions that harness them are being transformed by rapid change. We are part of a team around the globe working to improve life's essential products like food, clothing, water, transportation, medical and technology. The company makes products ranging from interconnect components to collimators to complex fiber optic assemblies used in a wide range of industries. This Molex facility works with custom fiber optic assemblies, bundles, and specialty fibers including gold and aluminum metalized fibers for industrial and medical applications.

What You Will Do

• 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
• Create 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

Who You Are (Basic Qualifications)

• Bachelor's Degree in engineering or science
• Engineering experience in a manufacturing or industrial environment

What Will Put You Ahead

• Experience with either ISO 9001 or ISO 13485
• Experience with specialty optical fibers or fiber optic assemblies
• Knowledge of DOE and Regressions Analysis
• 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.

Hiring 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 .

Who We Are

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.

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 Benefits

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, 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.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Equal Opportunities

Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click here for additional information.