Quality Compliance Specialist

Phillips Medisize, a Molex company is seeking a Quality Compliance Specialist to support the divisional Quality Compliance team. The Quality Compliance Specialist is an integral role dedicated to enhancing compliance and quality standards across all sites. This position is ideally suited for an ambitious professional seeking to leverage their expertise in regulatory compliance and quality assurance to drive significant impact within a dynamic environment.

As a key player in our Quality Assurance team, you will manage audits, oversee quality systems, and ensure regulatory adherence while supporting continuous improvement initiatives and fostering a culture of excellence.

* This is an onsite position that can be based out of Hudson, New Richmond, or Menomonie.

You will work with a diverse team of Quality and Regulatory professionals to assess compliance and deliver multi-disciplinary solutions across the organization. The divisional Quality Compliance Team supports all sites within Phillips Medisize providing guidance and a combined regulatory and quality strategy.

• Ensure compliance with GMP and relevant regulations and standards across multiple sites.
• Lead investigations, CAPAs, and change control processes.
• Act as a subject matter expert on quality topics, advising on policies and compliance decisions.
• Manage internal and external audits, and host regulatory inspections.
• Collaborate with teams to address audit findings and enhance compliance.
• Conduct gap assessments and recommend strategies for regulatory compliance.
• Support and manage Quality Management System (QMS) processes.
• Deliver training programs to enhance compliance with QMS requirements.
• Drive quality improvement projects using data analytics to identify trends.
• Travel 10% - 20% for audits and compliance activities.

• Bachelor’s degree in quality management, Chemistry, Microbiology, Regulatory Affairs, or a related field OR 5+ years of experience in Quality Assurance within a regulated industry.
• Experience in cGMP manufacturing and quality assurance practices.
• Strong understanding of FDA, ISO, and GMP requirements.
• Experience with data analysis and reporting tools (Excel, PowerPoint, Power BI).

• ISO 13485:2016/ ISO 9001:2026 Lead auditor certification or equivalent.
• Experience with quality management systems and regulatory compliance.
• Knowledge with IATF 16949, AS9100, DSCSA requirements.
• Experience or in-depth knowledge of medical device and/or pharmaceutical manufacturing processes.

This position does not qualify for VISA Sponsorship.

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.

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.

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 .

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 goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our…