Quality Compliance Leader, GMP & ISO (Onsite)

Phillips Medisize; Menomonie (WI); On-site; USD 75,000 - 110,000; Full time

Job summary

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to strengthen regulatory and quality standards across all sites. The role focuses on audits, QMS oversight, and driving CAPAs and continuous improvement in a fast-paced environment.

The position is onsite, with locations in Hudson, New Richmond, or Menomonie, Wisconsin, and includes training and collaboration with cross-functional teams to ensure FDA/ISO/GMP compliance.

Qualifications

• Bachelor’s degree in quality management, chemistry, microbiology, regulatory affairs, or 5+ years QA in 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).

Responsibilities

• Ensure GMP compliance 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.

Skills

Attention to detail

Regulatory compliance mindset

Education

Bachelor’s degree in quality management, chemistry, microbiology, regulatory affairs, or related field

5+ years of experience in Quality Assurance within a regulated industry

Tools

Excel

PowerPoint

Power BI

Job description

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to strengthen regulatory and quality standards across all sites. The role focuses on audits, QMS oversight, and driving CAPAs and continuous improvement in a fast-paced environment.

The position is onsite, with locations in Hudson, New Richmond, or Menomonie, Wisconsin, and includes training and collaboration with cross-functional teams to ensure FDA/ISO/GMP compliance.