Quality Engineer

Your Job

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 Qu...