Quality Engineer

Your Job Phillips Medisize, a Molex Company, is seeking a Quality Engineer to join our team in Menomonie, Wisconsin. This role will support, organize, and coordinate activities of the quality function with the goal of providing products/services that meet customer expectations. Devise and implement continuous improvement methodology supporting manufacturing, support groups and ensure customer satisfaction is maintained. Our Team Phillips Medisize, LLC, a Molex company, is a leading global provider of medical molding and assembly services. What You Will Do

• Ensure compliance with

FDA 21 CFR 820 210

211, ISO 13485, and

ISO 14971.

• Review specifications and ensure adherence to material and process requirements.
• Oversee validation and verification of manufacturing processes and equipment.
• Manage documentation for change management and non-conformance reports.
• Lead investigations and root cause analysis of non-conformances.
• Author tech reports, CAPAs, compliant investigations, and validations.
• Work with suppliers to meet quality requirements.
• Support customer complaint management.
• Troubleshoot manufacturing and field issues.
• Analyze quality data and trends; identify improvement areas.
• Champion continuous improvement initiatives.
• Collaborate with cross-functional teams. Who You Are (Basic Qualifications)
• Bachelor's degree or Associates Degree with 2+ years of experience
• Minimum of 2 years of quality-related experience
• Working knowledge of regulatory requirements including

FDA 21 CFR 820, ISO 13485

• Strong technical writing and problem-solving skills What Will Put You Ahead
• Experience in supplier quality management
• Pharmaceutical experience 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 hel...