Quality Engineer

Your Job

Phillips-Medisize, a Molex company is seeking a Quality Engineer to join our team in Hudson, Wisconsin at our Research and Development - North America facility.

This role will lead, 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

At Phillips Medisize, our goal is to create value for others.

We empower every team member to hear, feel and see the quality in every action we take.

By incorporating quality into the design of products and processes and predicting potential quality problems before manufacturing and delivering the product, we can create mutual benefit.

The leading task of quality control involves enforcing the use of specified processes and materials, ensuring the qualification of operators and equipment, and making a series of planned measurements to determine if quality standards are being met.

What You Will Do



* Ensure compliance with FDA 21 CFR 820, 21 CFR 210/211, ISO 13485, ISO 14971, and other applicable quality system requirements.


* Lead validation and verification activities for manufacturing processes, equipment, and quality systems.


* Review product specifications, materials, and manufacturing processes to ensure quality, safety, and regulatory compliance.


* Manage quality system documentation, including change controls, nonconformance reports, investigations, CAPAs, and validation records.


* Investigate quality issues, perform root cause analysis, and implement corrective and preventive actions to drive sustainable solutions.


* Partner with suppliers and internal stakeholders to ensure quality requirements are met and continuously improved.


* Support customer complaint investigations and provide technical expertise to resolve manufacturing and field quality issues.


* Analyze quality metrics and trends to identify risks, improve performance, and reduce recurring issues.


* Champion continuous improvement initiatives that enhance product quality, compliance, and operational effectiveness.


* Collaborate across Engineering, Operations, Regulatory, and Quality teams while mentoring and supporting the development of junior engineers.

Who You Are (Basic Qualifications)



* Bachelor's degree in an Engineering related field


* 5+ years Quality/Regulatory experience


* Experience with an ERP system, SAP preferred


* Data analysis experience

What Will Put You Ahead



* Strong understanding of quality systems, risk management, and continuous improvement methodologies.


* Ability to investigate nonconformances, identify root causes (CAPA), and implement effective corrective actions.


* Experience interpreting technical drawings, specifications, and regulatory or customer requirements.


* Ex...