Quality Engineer

About the role

Phillips Medisize, a Molex Company, is seeking a Quality Engineer to join our team in Menomonie, Wisconsin. This role supports, organizes, and coordinates activities of the quality function to provide products/services meeting customer expectations. The role also devises and implements continuous improvement methodologies supporting manufacturing, support groups, and ensures customer satisfaction.

Responsibilities

• 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.
• Maintain PFMEA/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.

Qualifications

• Bachelor's degree or Associates Degree OR equivalent 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.

Preferred Qualifications

• SAP experience.
• Injection molding experience.

What Will Put You Ahead

• SAP experience.
• Injection molding experience.

Pay

(Details not specified)

Schedule

(Details not specified)

Benefits

(Details not specified)