Your Job
Phillips Medisize, a Molex Company, is seeking a contribution-motivated
Quality Manager to join our team in our
Bangpakong, Thailand location. You will create value by stewarding Sustaining Quality with your expertise in the manufacturing and assembly of cables, connectors and fiber optics for medical devices, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.
Our Team
Phillips Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries. We work collaboratively within our Global Quality Organization to deliver compliant and effective solutions to our customers.
What You Will Do
- Ensure compliance with regulatory requirements and internal procedures including notified body and regulatory inspection support
- Communicate and demonstrate a vision for a vision of quality, through performing at both the strategic and tactical levels
- Support quality functions of day-to-day manufacturing operations
- Provide coaching and development to your team of leaders, and ensure your entire organization is leveraging its individual and collective comparative advantage
- Serve as the Management Representative, whose primary responsibility is to ensure that the facility meets internal policies and requirements, 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 manufacturing facility
- Participate and drive continual improvement/innovation, corrective action and internal/external customer satisfaction
- Actively contribute to a safe and inclusive workplace environment
Who You Are (Basic Qualifications)
- Bachelor's degree or higher in 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, 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 but not limited to ISO 13485, FDA Quality System Regulations, ISO 14971, and relevant international standards
What Will Put You Ahead
- Competency in statistical tools and process validation
- Effective cross-functional collaborator with teams such as Regulatory Affairs and Operations
- Proven expertise in managing regulatory inspections, audits, and developing effective response strategies
