Quality Compliance Specialist

About the Role

Phillips Medisize, a Molex company, is seeking a Quality Compliance Specialist to support the divisional Quality Compliance team. This is an onsite position that can be based out of Hudson, New Richmond, or Menomonie.

Our Team

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.

Responsibilities

• 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.

Qualifications

• 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).

Skills

What Will Put You Ahead:

• ISO 13485:2016/ ISO 9001:2015 Lead auditor certification or equivalent.
• Experience with quality management systems and regulatory compliance.
• Knowledge of 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.