Training Specialist

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

Learning & Development Specialist

A global manufacturing organisation with regional operations across multiple sites. The company operates within a structured HR and plant-based model, with L&D functions spanning both site-level execution and regional collaboration. The role sits within a broader global L&D team supporting organisational capability development.

 

ROLE PURPOSE

The Learning & Development Specialist is responsible for designing, delivering, and managing learning programmes that support site and regional capability development. The role serves as the primary L&D resource on-site whilst operating as an integrated member of a regional team, ensuring alignment between local training needs and broader organisational goals. The position holds accountability for end-to-end training administration, effectiveness measurement, and compliance.

RESPONSIBILITIES

Programme Design & Delivery 

• Design, develop, and deliver learning programmes covering onboarding, technical training, leadership development, and soft-skills workshops
• Develop training materials, manuals, e-learning modules, and job aids at both site and regional level
• Facilitate group training sessions and workshops
• Recommend training methodologies and learning technologies to improve programme effectiveness

 

Training Needs & Effectiveness

• Conduct skills gap analyses and training needs assessments in collaboration with department managers
• Administer assessments, surveys, and evaluations
• Evaluate training effectiveness using qualitative and quantitative methods and recommend improvements
• Analyse training data and drive continuous improvement opportunities

 

LMS & Content Management

• Maintain and update the Learning Management System (LMS); ensure content accuracy and user access
• Track and record training participation and compliance
• Maintain L&D documentation, training calendars, and compliance records
• Take overall responsibility for setting up and maintaining training master data governance

 

Regional & Global Collaboration

• Operate as the site-based Thailand resource within a regional L&D team
• Act as the conduit between the site and global L&D function
• Work with site leadership to support development of annual site training plans aligned to strategy and vision
• Work with the Global Corporate Training team and all departments to create and maintain the training site matrix
• Own L&D quarterly plans, ensuring alignment with site, regional, and organisational goals
• Up to 20% regional travel required; flexibility for global time zones required

 

Organisational Development Support

• Support organisational development initiatives including performance management, talent development, and succession planning
• Support career development programmes and coaching initiatives
• Manage vendor relationships for external training providers
• Manage assigned L&D budget within defined limits

 

Compliance & Reporting

• Prepare and report training performance results and KPIs to HR leadership
• Provide all required training information and submit to government agencies per legal requirements, ensuring full compliance
• Serve as the training SME to support all types of audits and quality documentation related to training
• Coordinate with external parties and organise training sessions for the site

 

SKILLS & EXPERIENCE

• Education: Bachelor's degree in Human Resources, Education, Psychology, Business Administration, or related field
• Experience: 2–5 years in Learning & Development or a related HR function; experience designing and delivering training programmes; experience in cross-functional and/or matrix environments
• Technical: LMS management and e-learning content creation; digital learning tools; full Microsoft Office suite; SAP experience an advantage
• Leadership: Superior consulting, facilitation, communication, and influencing skills; ability to adapt style across all levels of management and employees; strong project management and prioritisation capabilities; collaborative working style across diverse teams and organisational levels
• Certifications: Professional qualification in L&D, training, or instructional design preferred (e.g., CPTD, ATD, CIPD, or equivalent)
• Industry: Manufacturing or industrial sector with multi-site / regional operating model preferred