Quality Engineer

Your Job

Phillips-Medisize, a Molex Company, is seeking a Quality Engineer to join our facility in Menomonie, WI.

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.

This role will be based out of our Menomonie, WI location.

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)

Bachelor's degree or equivalent experience

Minimum of 4 years of quality-related experience in a medical manufacturing environment

Experience working in a regulated environment

Knowledge of automated assembly and test procedures

Working knowledge of regulatory requirements including FDA 21 CFR 820, ISO 13485

Experience working with an ERP system (SAP)

Strong data analysis skills

Strong technical writing and problem-solving skills

Experience in packaging, serialization, sterilization, and complaint handling

Experience with updating the test procedures in testing equipment

What Will Put You Ahead

Experience in supplier quality management

Pharmaceutical experience

This position does not qualify for VISA Sponsorship.

LI-SD5

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