Quality Manager, Management Representative

About the Company

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our team in Bangpakong, Thailand. The company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries and works collaboratively within a Global Quality Organization to deliver compliant and effective solutions to customers.

Responsibilities

• Ensure compliance with regulatory requirements and internal procedures, including notified body and regulatory inspection support
• Communicate and demonstrate a vision for quality at both strategic and tactical levels
• Support quality functions of day-to-day manufacturing operations
• Provide coaching and development to leaders and ensure the organization leverages its individual and collective comparative advantage
• Serve as the Management Representative to ensure the facility meets internal policies, customer requirements, and divisional quality systems
• Monitor key performance indicators (KPIs) and drive improvement
• Ensure compliance with cGMP, ISO, and regulatory requirements
• Act as a communication liaison between the customer and the manufacturing facility
• Participate in and drive continual improvement, corrective actions, and internal/external customer satisfaction
• Actively contribute to a safe and inclusive workplace environment

Qualifications

• Bachelor’s degree or higher in a scientific discipline
• 5+ years of experience in Quality Assurance within the medical device or biotechnology industry
• 5+ years of management experience
• Proficiency in quality management tools, technical writing, and methodologies (e.g., risk assessment, root cause analysis, FMEA)
• Strong analytical skills for data analysis and trend identification
• Proven experience with quality system requirements for regulated products, including ISO 13485, FDA Quality System Regulations (QSR), ISO 14971, and relevant international standards
• Competency in statistical tools and process validation (preferred)
• Effective cross-functional collaboration with teams such as Regulatory Affairs and Operations and proven expertise in managing regulatory inspections, audits, and developing effective response strategies (preferred)