Quality Compliance Specialist

Phillips Medisize (a Molex company)

About the Role

Phillips Medisize is seeking a Quality Compliance Specialist to support the divisional Quality Compliance team. This role is dedicated to enhancing compliance and quality standards across all sites.

Key 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.

Requirements & Tech Stack

• 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).

Qualifications That Will Put You Ahead

• 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.