Senior Quality Management System Engineer

A leading global medical device manufacturing and production industry is seeking a Senior Quality Management Systems Engineer to join their Penang site.

This Senior Quality Management System Engineer offers you the opportunity to play a pivotal part in developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet both internal and external requirements. You will be empowered as a subject matter expert on Corrective and Preventive Action (CAPA) systems, internal and external audit processes, and regulatory compliance. The organisation is committed to fostering an inclusive environment where your expertise will be valued and your professional growth supported through ongoing training opportunities. Flexible working arrangements are available to help you balance your career ambitions with personal commitments. If you are passionate about quality assurance and eager to make a meaningful impact within a supportive network of professionals, this is the perfect opportunity for you.

• You will have the chance to lead quality initiatives that directly influence departmental, site, divisional, and corporate goals while enjoying flexible working opportunities tailored to your needs.
• The organisation provides generous pension contributions and comprehensive training programmes designed to enhance your skills and support your long-term career development.
• You will work within a knowledgeable team that values collaboration, inclusivity, and dependable support, ensuring you feel connected and empowered every step of the way.

What you'll do:

As a Senior Quality Management System Engineer, you will be entrusted with responsibilities that span regulatory compliance, audit management, process improvement, and cross-functional collaboration. Your day-to-day activities will involve implementing robust quality systems aligned with both internal standards and external regulations. You will conduct thorough audits—both internally and externally—to identify areas for improvement while supporting corrective actions through effective CAPA management. By participating in global meetings and collaborating across business units, you will help standardise quality policies throughout the organisation. Your analytical skills will be put to use as you gather metrics for management reviews and analyse process data from different parts of the company. Additionally, you may provide quality assurance support to laboratories responsible for testing drug combination products and raw materials. Success in this role requires a keen eye for detail, strong interpersonal skills for educating teams on quality requirements, and a commitment to continuous improvement within a supportive environment.

• Implement internal requirements as well as external laws, regulations, guidance, and standards relevant to quality systems at the Penang site.
• Utilise expertise in internal auditing techniques to ensure compliance with FDA, ISO, cGMP, MDR, and other applicable standards.
• Lead and support site external inspections by planning, coordinating, and conducting scheduled audits to assess compliance with regulatory and internal requirements.
• Manage audit scheduling, investigation of findings, evaluation of audit observations, and identification of areas for improvement or potential noncompliance.
• Attend global conference calls and meetings related to the internal audit process to share insights and collaborate with colleagues across business units.
• Drive the implementation of assurances, process controls, and CAPA systems designed to meet or exceed all requirements.
• Support corrective and preventive actions processes at the site by maintaining the CAPA process and distributing metrics for facility management.
• Work closely with CAPA phase owners to ensure timely completion of actions while educating functional areas on quality system requirements.
• Participate cross-functionally to standardise policies and procedures across business units within the organisation’s Quality System framework.
• Gather facility quality metrics for management review presentations; collect and analyse business/quality system process data from various departments.

What you bring:

To excel as a Senior Quality Management System Engineer, you will bring proven experience in regulated industries—ideally within medical devices—alongside strong technical qualifications in science or engineering. Your background should include hands-on involvement with batch release processes, non-conforming event management, CAPA systems implementation, audit coordination (internal/external), and presenting management reviews. Deep understanding of ISO13485 standards combined with knowledge of EU MDR and FDA regulations will enable you to maintain compliance across multiple jurisdictions. Familiarity with cGMP principles is crucial when providing support for laboratory assessments involving drug combination products or raw materials. Your interpersonal skills will shine as you educate teams on quality system requirements while collaborating across functions to standardise policies. Dependability is key; your ability to connect with colleagues ensures successful outcomes in both routine tasks and complex projects.

• Degree qualification in science or engineering is required for this position as it forms the foundation of your technical expertise.
• Experience in the medical device industry is highly desirable as it ensures familiarity with sector-specific regulations and practices.
• Proven experience in Analytical Finished Goods Batch Release demonstrates your ability to manage product testing processes effectively.
• Hands-on involvement with non-conforming events and CAPA processes showcases your problem-solving abilities within regulated environments.
• Internal audit or external audit experience is essential for assessing compliance with regulatory standards such as FDA, ISO13485, EU MDR, cGMP.
• Management review experience highlights your capacity to present complex quality metrics clearly to senior stakeholders.
• Comprehensive knowledge of ISO13485 standards ensures you can implement best practices in medical device manufacturing.
• Understanding of EU MDR regulations allows you to navigate European market requirements confidently.
• Familiarity with FDA regulations equips you to maintain compliance with US standards for medical devices.
• Knowledge of cGMP principles as well as Combination Device Regulations supports your ability to oversee laboratory assessments effectively.

What sets this company apart:

This organisation stands out for its unwavering commitment to quality excellence within the medical device sector. Employees benefit from flexible working opportunities that promote work-life balance alongside generous pension contributions that secure their financial future. Comprehensive training programmes are offered regularly so you can continue developing professionally while staying up-to-date with evolving industry standards. The culture here is inclusive—every team member’s voice matters—and collaboration is encouraged at all levels. Supportive leadership ensures that you always have access to guidance when needed; whether you're navigating regulatory changes or spearheading new initiatives. The Penang site itself is renowned for its state-of-the-art facilities dedicated exclusively to advancing healthcare solutions globally. Joining this team means becoming part of a network where knowledge sharing is celebrated—and where your dependability makes a real difference every day.

What's next:

If you are ready to take your career in quality management systems engineering to new heights within an inclusive environment that values your expertise—apply now!

Apply today by clicking on the link provided or email me at jackelyn.wong@robertwalters.com to discuss this new opportunity!

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C