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Quality Director - Medical Device / Semicon/ PCBA (Johor)

Malaysia Permanent View Job Description
The Director serves as the primary Quality representative for the Malaysia manufacturing facility, partnering closely with site and global stakeholders to ensure manufacturing processes consistently deliver safe, effective, and high-quality products.
  • Work for a leading medical device manufacturer.
  • Competitive benefit package.

About Our Client

A leading medical device manufacturer based in Johor.

Job Description

  • 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.

The Successful Applicant

  • Bachelor's Degree in Engineering, Science, or a related discipline.
  • 15+ years of experience within Medical Device Quality Operations, including at least 12 years in a senior Quality leadership capacity.
  • Has strong track record in driving improvement & culture within the company.
  • Strong expertise across Quality Assurance, Quality Control, Quality Engineering, Incoming Quality, and Quality Systems.
  • Deep knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, CAPA, audit management, and manufacturing quality systems.
  • Experience within high-volume medical device or electromechanical manufacturing environments is highly preferred.
  • Proven track record of leading large teams, driving site quality performance, and influencing stakeholders in a global matrix organization.
  • Strong analytical and problem-solving capabilities with experience leveraging data analytics and business intelligence tools such as Power BI.

What's on Offer

  • Competitive salary ranging from MYR 28800 to MYR 32000.
  • Permanent role with opportunities for professional growth.



If you are ready to move forward in your career as a Quality Director in the healthcare industry, we encourage you to apply.

Contact
Erni Susanto
Quote job ref
JN-092026-7107781
Phone number
+603 2302 4033

Job summary

Function
Engineering & Manufacturing
Specialisation
Quality, Technical
What is your area of specialisation?
Industrial / Manufacturing
Location
Malaysia
Contract Type
Permanent
Consultant name
Erni Susanto
Consultant contact
+603 2302 4033
Job Reference
JN-092026-7107781

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.