Quality Specialist

Job Title: Quality Specialist

Company: Phillips-Medisize, LLC

Location: Menomonie, WI

What you will do:

The Quality Specialist plays a crucial role in maintaining and enhancing the Quality Management System (QMS) by ensuring compliance with regulatory standards, supporting audits, and driving continuous improvement initiatives.

This role requires collaboration across departments, a commitment to personal and professional growth, and the ability to foster a positive and respectful workplace culture.

Key Responsibilities:

• Review and release change records, maintaining accuracy and timeliness.


* Periodic review reporting of site Quality Management System (QMS) documents, ensuring they are current.


* Gather/ share essential documentation requested in support of audit activities.


* Collaborate with cross-functional teams to ensure audit readiness.



* Submit and participate in Continuous Improvement Projects to enhance processes and workflow efficiency.


* Lead initiatives such as document organization, process standardization, and transitioning systems for improved functionality.



* Act as a backup for key roles as needed, including quality specialists in other locations.


* Review and address compliance issues in Change and Nonconformance Records.


* Ensure adherence to work instructions and regulatory requirements through meticulous reviews and proactive communication.

Requirements:

• Experience in manufacturing OR Quality

What Will Put You Ahead:


* Experience working in a quality environment


* GMP, ISO 9001, ISO13485, and 21 CFR Part 210/211


* Experience using SAP/ERP system

LI-SD5

At Koch companies, we are entrepreneurs.

This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions.

Any compensation range provided for a role is an estimate determined by available market data.

The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location.

If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Hiring Philosophy

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds.

We are Military Ready and Second Chance employers.

Learn more about our hiring philosophy here .

Who We Are

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense.

We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.

At Koch, employees are empowered to do what they do best to make life better.

Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Our Benefits

Our goal is fo...