Quality Director: Medical Device Quality & Ops Leader

Michael Page; Kuala Lumpur; On-site; MYR 321,000 - 357,000; Full time

Benefits offered by this job

Competitive salary

Permanent role with growth

Job summary

Michael Page Malaysia is recruiting a Senior Director of Quality Operations for a leading medical device manufacturer in Johor. You will lead QA, QC, and QE teams, drive regulatory compliance, and shape the site quality strategy.

Ideal candidate brings 15+ years in medical device quality operations, including senior leadership, with deep ISO 13485/FDA/EU MDR expertise and a track record of delivering site-wide improvements. This is a permanent role with growth opportunities.

Qualifications

• 15+ years of experience in Medical Device Quality Operations.
• At least 12 years in a senior Quality leadership capacity.
• Strong track record of driving improvement & culture within the company.
• Deep knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, CAPA, audit management, and manufacturing quality systems.
• Experience in high-volume medical device manufacturing environments.
• Proven track record of leading large teams in a global matrix organization.
• Strong analytical and problem-solving capabilities with data analytics tools such as Power BI.

Responsibilities

• Lead and develop teams across Quality Assurance, Quality Control, and Quality Engineering, fostering a high-performance culture and strong cross-functional collaboration.
• Oversee all factory quality activities from incoming inspection through final product release, ensuring compliance with regulatory and quality requirements.
• Drive site-wide quality strategy, quality objectives, and continuous improvement initiatives.
• Ensure effective management of investigations, non-conformances, CAPAs, and audit findings, with timely implementation of corrective and preventive actions.
• Maintain a robust Quality Management System (QMS) in compliance with FDA, ISO 13485, EU MDR, and applicable regulatory standards.
• Lead internal, external, customer, and regulatory audits as the site's Management Representative.
• Ensure effectiveness of quality planning, training programs, environmental monitoring, and statistically based quality control processes.
• Partner with global and regional stakeholders to drive harmonization, standardization, and operational excellence initiatives.
• Own the Quality Operations budget and provide strategic quality leadership for the Malaysia manufacturing site.

Skills

Quality leadership

Team leadership

Regulatory compliance

Cross-functional collaboration

Data analytics

Education

Bachelor's Degree in Engineering/Science or related discipline

Tools

Power BI

QMS systems

Job description

Michael Page Malaysia is recruiting a Senior Director of Quality Operations for a leading medical device manufacturer in Johor. You will lead QA, QC, and QE teams, drive regulatory compliance, and shape the site quality strategy.

Ideal candidate brings 15+ years in medical device quality operations, including senior leadership, with deep ISO 13485/FDA/EU MDR expertise and a track record of delivering site-wide improvements. This is a permanent role with growth opportunities.