Head of Quality

1 day ago

Kampung Bukit Minyak, Penang, Malaysia BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD. Full time 150,000 - 250,000 per year

Job Description

1. Role Overview

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
  • ISO Risk Management)
  • 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
  • R&D: design controls, risk management, usability
  • 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.

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