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Phillips Medisize · 7 hours ago

Quality Engineer

Menomonie, WI

Full-time

Onsite

Entry, Mid Level

2+ years exp

Phillips Medisize, a Molex Company, is seeking a Quality Engineer to join their team in Menomonie, Wisconsin. The role focuses on supporting and coordinating quality functions to ensure products meet customer expectations while implementing continuous improvement methodologies.

Health CareHealth DiagnosticsManufacturingOutsourcing

No H1B

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

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

Qualification

FDA 21 CFR 820ISO 13485Quality-related experienceSupplier quality managementTechnical writingProblem-solvingContinuous improvementRoot cause analysisCross-functional collaboration

Required

Bachelor's degree or equivalent experience

Minimum of 2 years of quality-related experience in a medical manufacturing environment

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

Strong technical writing and problem-solving skills in CAPA documentation and change management documentation

Experience in packaging, serialization, sterilization, and complaint handling

Preferred

Experience in supplier quality management

Pharmaceutical experience

Benefits

Medical

Dental

Vision

Flexible spending and health savings accounts

Life insurance

ADD

Disability

Retirement

Paid vacation/time off

Educational assistance

Infertility assistance

Paid parental leave

Adoption assistance

Company

Phillips Medisize

As a contract development and manufacturing organization (CDMO), the world’s leading pharmaceutical, medtech and in vitro diagnostic companies trust us to help them design and manufacture their products.

Founded in 1964

Hudson, Wisconsin, USA

5001-10000 employees