Head of Quality

Bactiguard; Seberang Perai; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical device company in Penang is seeking a Quality Senior Manager/Director to lead the Quality Management System and ensure compliance with global regulations. The ideal candidate should have over 20 years of experience in Medical Device Quality Assurance and a strong track record in senior leadership roles. Responsibilities include overseeing quality processes, leading a high-performing team, and collaborating with various departments. This position offers a dynamic work environment and contributes to the development of safe, effective products.

Qualifications

• 20+ years of experience in Medical Device Quality Assurance.
• At least 5 years in senior leadership roles.
• Strong track record with global regulatory authorities.

Responsibilities

• Develop a clear quality vision and strategic roadmap.
• Lead and mentor a high-performing Quality team.
• Maintain and enhance the QMS in compliance with regulations.
• Oversee product lifecycle quality activities and quality metrics.

Skills

Quality Management Systems

Regulatory Compliance

Leadership

Supplier Quality Management

Statistical Process Control

Root Cause Analysis

Education

Bachelor’s or Master’s degree in engineering or life sciences

Professional certifications such as CQE, CQA

Job description

The Quality Senior Manager/Director is responsible for establishing, leading, and continuously improving the company’s Quality Management System (QMS) to ensure full compliance with global medical device regulations and standards. This role oversees quality assurance, quality engineering, supplier quality, document control, and quality operations to support the development, manufacturing, and commercialization of safe, effective, and compliant medical devices throughout the entire product lifecycle.

2. Key Responsibilities

2.1 Quality Strategy & Leadership

Develop a clear quality vision and strategic roadmap supporting product innovation, compliance, and operational excellence.

Lead, mentor, and build a high-performing Quality team (QA, QE, Quality Systems, Supplier Quality, Document Control).

Advise executive leadership on quality risks, compliance status, and performance metrics.

2.2 Quality Management System (QMS) Oversight

Maintain and enhance the QMS in compliance with:

• ISO 13485
• FDA 21 CFR Part 820 (QSR)
• EU MDR/IVDR
• MDSAP requirements

Ensure strong documentation control, record management, and effective change management processes.

2.3 Product Lifecycle Quality

Oversee Design Controls, Verification & Validation, Risk Management, and Usability Engineering activities.

Ensure quality review and approval of DHF, DMR, technical documentation, and product specifications.

Support Design Transfer and ensure fully validated manufacturing processes (IQ/OQ/PQ).

2.4 Manufacturing & Operations Quality

Lead NCR, CAPA, and continuous improvement processes.

Ensure robust in-process controls, final inspection, release, and manufacturing quality systems.

Oversee statistical process controls, process monitoring, and product quality metrics.

2.5 Supplier & External Manufacturing Quality

Develop and maintain a strong supplier quality management program, including:

• Supplier qualification and auditing
• Quality agreements
• Supplier corrective actions and continuous improvement

Ensure oversight of contract manufacturers, sterilization providers, and critical service suppliers.

2.6 Post-Market Quality & Vigilance

Oversee global complaint handling, failure investigation, root cause analysis, and trend analysis.

Partner with Regulatory Affairs on reporting obligations (MDR, vigilance reports, FSCAs, FDA MDRs).

Lead quality components of Post-Market Surveillance (PMS) and PMCF activities.

2.7 Audits & Regulatory Inspections

Plan and conduct internal audits, supplier audits, and MDSAP audits.

Lead company readiness and response for FDA inspections, Notified Body audits, and global regulatory inspections.

Ensure effective and timely implementation of corrective and preventive actions.

2.8 Cross-Functional Collaboration

Collaborate closely with:

• Regulatory Affairs: submissions, regulatory strategy, technical documentation
• Operations & Manufacturing: validation, process control, continuous improvement
• Clinical & Medical: complaints and post-market insights
• Commercial: quality support for customer issues and market feedback

3. Competence & Capability Requirements

3.1 Education

Bachelor’s or Master’s degree in engineering, life sciences, or a related technical field.

Professional certifications such as CQE, CQA, or equivalent ASQ credentials are strongly preferred.

3.2 Experience

20+ years of experience in Medical Device Quality Assurance, including at least 5 years in senior leadership roles.

Proven experience working with ISO 13485, FDA QSR, EU MDR/IVDR, and ISO 14971.

Strong track record interacting with FDA, Notified Bodies, and other global regulatory authorities.