Quality Engineer

The Quality Engineer at Phillips Medisize in Phoenix, AZ is responsible for maintaining the Polymicro Quality Management Systems, developing, implementing, and improving the Quality System to meet both internal and external customer needs, and ensuring compliance with ISO 9001, ISO 13485, and FDA regulations.

About the Role

Molex is a global team dedicated to transforming essential products through innovative solutions in data, technology, and complex electronic systems. This facility specializes in custom fiber optic assemblies, bundles, and specialty fibers for various industries including food, clothing, water, transportation, medical, and technology.

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
• 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 applicable requirements
• 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

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

• Medical, dental, vision, flexible spending and health savings accounts
• Life insurance, ADD, disability, retirement
• Paid vacation/time off, educational assistance
• May include infertility assistance, paid parental leave and adoption assistance

Hiring Philosophy: Koch companies value diversity and are committed to equal opportunities for all employees. We are also Military Ready and Second Chance employers. Our benefits package includes comprehensive health coverage, retirement plans, and a variety of other perks designed to support the overall wellbeing of our employees.