Senior Manufacturing Operations QA Manager

AMS; Kulim; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading MedTech organization is seeking a Senior Quality Assurance Manufacturing Operations Manager in Malaysia. In this role, you will oversee the Quality System development and ensure compliance with regulatory standards. The ideal candidate will have extensive experience in the regulated manufacturing sector, particularly in quality systems and team leadership. This position offers a competitive package, international training opportunities, and the chance to make a significant impact in the healthcare field.

Benefits

Competitive salary

Incentives

Medical coverage

Paid leave

International training

Qualifications

• 7+ years of relevant experience with 5+ years in managerial roles.
• Experience in a regulated manufacturing industry (Pharma, MedTech).
• Proven ability to build and lead quality teams and systems.

Responsibilities

• Lead development and oversight of the Quality System.
• Ensure compliance with global quality standards.
• Manage quality assurance and control systems.

Skills

Quality System Regulations (FDA)

ISO standards

EU MDR

Bilingual communication skills (English, Malay)

Project management

Education

Bachelor’s degree

Advanced degree

Job description

Senior Manufacturing Operations QA Manager

Join a transformative MedTech player, poised to expand in Malaysia and shape the region’s healthcare ecosystem.

We are looking for an experienced Senior Quality Assurance Manufacturing Operations Manager, on behalf of our client, a well-established, high-impact organisation in the Medtech sector. The company is entering a strategic growth phase, particularly in Malaysia, and is looking for someone with experience in building and leading quality systems in a regulated manufacturing environment, with good knowledge of FDA, ISO and EU MDR requirements.

About this role:

As a Senior Quality Assurance Manufacturing Operations Manager, you will be responsible for leading the development, implementation and oversight of the Quality System at the client’s Malaysia manufacturing facility, ensuring products manufactured are compliant with all applicable quality system requirements. You will drive operational excellence, ensure compliance with global quality standards and foster a culture of quality and patient-first thinking.

Your responsibilities

• Building the quality function from the ground up, including team structure, establishing roles and responsibilities, hiring and quality process implementation.
• Leading the development and maintenance of quality systems and ensuring compliance with internal policies and external regulations.
• Interpreting regulatory and governmental requirements and providing guidance to ensure operational compliance.
• Establishing strategic quality programs to support product development, transfer and technology implementation, ensuring products and assemblies meet the applicable requirements.
• Leading audit and inspection preparation, regulatory interactions and managing findings resolution.
• Acting as the management representative for Malaysia and the primary point of contact for any regulatory queries related to quality systems and operations.
• Supporting other sites with quality system setup and implementation as needed.
• Driving harmonization, best practice sharing and alignment with global strategies.
• Managing quality assurance, control and liability systems related to materials, techniques and products.
• Supporting new product introduction (NPI), product transfer and new technologies implementation, requiring occasional travel abroad
• Travel internationally for at least 6 months to receive training, learn end-to-end processes, and gain exposure to global best practices.

Essential skills and experience

• Bachelor’s degree with a minimum of 7 years of relevant experience, including 5+ years in managerial roles or an advanced degree with a minimum of 5 years of experience.
• Minimum 5 years’ management experience in a regulated manufacturing industry (Pharma, MedTech, etc.).
• Familiarity of Quality System requirements with a working knowledge of Quality System Regulations (FDA), ISO standards and EU MDR.
• Proven ability to build and lead quality teams and systems in a manufacturing setting with global work experience and cross-functional leadership capabilities.

Desirable skills and experience

• Strong operational and financial acumen; project management experience is a plus.
• Effective bilingual communication skills (English and Malay – speaking/reading proficiency should be above average).
• Experience in People Leadership/ Management with at least 10 FTEs at supervisory or managerial level.

What’s in it for you

This role offers innovative projects, strong culture and excellent opportunities for career progression. Additionally, it’s an opportunity to be part of a transformative greenfield project that will contribute to our client’s ongoing commitment to improving healthcare globally while supporting local communities in Malaysia.

We offer a competitive package including salary, incentives, medical coverage and paid leave. This role also includes international training, providing exposure to global best practices and end-to-end processes.