Quality manager

V-53362

Location
Bang Pakong
Salary
THB120000 per month

Expertise and Skill Tags

Quality Manager

A global medical device contract manufacturer specializing in cables, connectors, and fiber optics. The organization serves regulated healthcare markets with a strong focus on compliance-driven manufacturing. This role is based at a high-volume production facility within the medical device sector.

Reports to: Vice President, Quality

 

ROLE PURPOSE

The Quality Manager is responsible for stewarding sustaining quality across manufacturing and assembly operations for medical device products. The role operates at both strategic and tactical levels, ensuring full compliance with regulatory requirements, customer expectations, and divisional quality systems. The position also serves as Management Representative for the facility's quality management system.

 

RESPONSIBILITIES

Regulatory Compliance & Quality Systems

  • Serve as Management Representative, ensuring the facility meets internal policies, customer requirements, and divisional quality system standards
  • Ensure compliance with cGMP, ISO 13485, FDA Quality System Regulations, ISO 14971, and relevant international standards
  • Support notified body and regulatory inspection readiness and response
  • Develop and maintain effective strategies for managing audits, inspections, and corrective action responses
Operations Quality Support

  • Support quality functions within day-to-day manufacturing operations
  • Act as communication liaison between customers and the manufacturing facility
  • Monitor Key Performance Indicators (KPIs) and drive performance improvement
  • Participate in and lead continual improvement and innovation initiatives
Leadership & Team Development

  • Provide coaching and development to a team of quality leaders
  • Ensure the quality organization leverages individual and collective strengths effectively
  • Communicate and demonstrate a clear vision for quality at both strategic and tactical levels
  • Actively contribute to a safe and inclusive workplace environment
Customer & Stakeholder Engagement

  • Drive internal and external customer satisfaction initiatives
  • Coordinate with Regulatory Affairs, Operations, customers, suppliers, and relevant authorities
  • Support corrective action processes across cross-functional teams
 

SKILLS & EXPERIENCE

  • Education: Bachelor's degree or higher in a scientific discipline
  • Experience: 5 years in Quality Assurance within medical device or biotechnology; 5 years in a management role
  • Technical: Quality management tools and methodologies including risk assessment, root cause analysis, and FMEA; statistical tools; process validation; technical writing; data analysis and trend identification
  • Leadership: Proven ability to lead quality teams, develop leaders, and collaborate cross-functionally with Regulatory Affairs and Operations
  • Certifications: Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations required; relevant quality certifications preferred
  • Industry: Medical device or biotechnology manufacturing in a regulated environment

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