Quality Engineer

Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our teams in Wisconsin. We have opportunities available at our New Richmond, Menomonie, and Hudson facilities. 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.

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.
• Mentor junior quality engineers.
• Collaborate with cross-functional teams.

Who You Are (Basic Qualifications)

What Will Put You Ahead

Equal Opportunities

Equal Opportunity Employer, including disability and protected veteran status. Some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please visit the following information for additional information : E-Verify.

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