Quality Engineer

Quality Engineer

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 to provide products and services that meet customer expectations. The position will devise and implement continuous improvement methodology supporting manufacturing and support groups, and ensure customer satisfaction is maintained.

Location:

Menomonie, Wisconsin Building:
Red Cedar

• Ensure compliance with FDA 21 CFR 820, 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 technical reports, CAPAs, compliant investigations, and validations.
• Maintain PFMEA and risk management documents.
• 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.

• Bachelor's degree or Associate’s degree, or equivalent experience.
• Minimum of 2 years of quality‑related experience.
• Working knowledge of regulatory requirements including FDA 21 CFR 820 and ISO 13485.
• Strong technical writing and problem‑solving skills.

• Experience with SAP.
• Experience in injection molding.

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 are set by the applicable Summary Plan Description, policy, or guideline, and benefits may vary by geographic region.

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.