Head of Quality Engineering

     

JOB DESCRIPTION:

Role Overview

The Head of Quality Engineering provides strategic leadership for the Quality Engineering function with accountability for Validation, Design Transfer, Risk Management, Quality Excellence, and Quality Support for Technical Manufacturing. The role ensures that products are transferred, manufactured, and sustained in alignment with global regulatory requirements, while enabling operational continuity, product performance, and a strong culture of quality.

This leader will provide quality oversight and direction for key global design transfer programmes. The role will also lead capability building through the development of best‑practice training modules and learning approaches that support these design transfer programmes, ensuring consistent, high‑quality execution across functions and sites.

The position partners closely with ID BU functions and local site based Quality Operations, Technical Operations, Operations, Regulatory Affairs, Supply Chain, and Post‑Market teams to strengthen lifecycle management and drive quality engineering excellence across the organisation.

Key Responsibilities

1. Validation Leadership

• Define the enterprise validation strategy across process, equipment, method, and software validation.
• Ensure validation approaches are risk‑based, standardised, and compliant with FDA, EU MDR, and ISO 13485.
• Lead development and maintenance of Validation Master Plans and validation lifecycle documentation.
• Build and strengthen technical capability across global sites.

2. Design Transfer Excellence

• Lead the quality operations design transfer framework for new products, major design changes, technology transfers, and global scale‑ups.

• Ensure effective application of DfX principles to support robust, reliable manufacturing.
• Govern operational preparedness for transfers.
• Strengthen collaboration between DQA, Technical Operations and Operations to support seamless introduction to manufacturing.

3. Risk Management

• Own and govern the product risk management process across the full lifecycle.
• Maintain risk documentation aligned with updated design knowledge, manufacturing changes, and field performance.
• Lead cross‑functional hazard analyses, FMEAs, and mitigation activities.
• Promote risk‑based quality decision making across engineering, operations, and leadership forums.

4. Quality Excellence & Continuous Improvement

• Define and execute the Quality Excellence roadmap with focus on capability, standardisation, and engineering discipline.
• Advance the use of data, metrics, and analytics (product & process monitoring) for proactive quality improvement.

• Develop and oversee training modules incorporating best‑practice learning methods in support of key design transfer programmes.
• Ensure training content is practical, scenario‑based, and aligned with global quality expectations to build strong cross‑functional capability.
• Support quality governance processes and contribute to strategic quality planning.

5. Quality Support for Technical Manufacturing

• Provide proactive, technically strong Quality Engineering support to the Technical Manufacturing organisation.
• Partner with manufacturing teams to drive robust investigations, root cause analysis, and sustainable corrective actions.
• Support process capability improvement, yield enhancement, and manufacturing robustness.
• Provide quality input into equipment qualifications, process development, automation, and scale‑up activities.
• Ensure timely and compliant support for deviations, nonconformances, and manufacturing issues.

6. Leadership & Talent Development

• Build, lead, and develop a high-performing team of Quality Engineers and specialists.
• Foster a culture of accountability, collaboration, and continuous improvement.
• Communicate effectively with senior stakeholders and influence cross‑functional decision-making.
• Strengthen organisational capability in validation, risk management, design transfer, and lifecycle quality.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Science, or a related technical discipline.
• 10+ years of experience in Quality, Engineering, or Product Development within a regulated industry.
• Strong leadership experience and proven ability to manage cross‑functional, global initiatives.
• Deep expertise in design transfer, validation, risk management, and sustaining engineering.
• Experience supporting manufacturing operations and technical problem-solving.
• Excellent communication, analytical, and organisational leadership skills.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ID Infectious Disease

        

LOCATION:

Korea > Yongin-si : 65 Borahagal-ro

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable