Regulatory Affairs-Jobs in Malaysia

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world‑class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

The Process Team Lead is responsible for leading a team of process engineers and technicians to ensure efficient, stable, and optimized manufacturing processes. The role requires both strong technical expertise and leadership capability to drive continuous improvement, resolve process‑related issues, and deliver operational excellence in line with business objectives.

• Lead and mentor a team of process engineers/technicians, providing technical guidance and career development support.
• Oversee day‑to‑day process operations, ensuring compliance with safety, quality, and regulatory requirements (FDA, ISO, GMP, etc.).
• Drive process improvement initiatives to improve yield, reduce cost, and increase equipment efficiency (OEE).
• Lead root cause analysis (RCA) and corrective/preventive actions (CAPA) for process deviations and production issues.
• Manage process validation, capability studies, and continuous improvement projects (Lean, Six Sigma, DOE, FMEA).
• Support company policies and procedures, goals and objectives, FDA regulations and good manufacturing practices.
• Collaborate with cross‑functional teams (Production, Quality, R&D, Maintenance, Supply Chain) to ensure smooth implementation of new project, project transfer and problem resolution.
• Plan, prioritize, and allocate resources to meet project and production deadlines.
• Monitor and report process performance metrics to management, highlighting risks and recommending improvements.
• Champion innovation and automation adoption to enhance process reliability and productivity.
• Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products.
• Monitor and control department’s performance to reduce waste, improve efficiency and quality of output at all operations.
• Manage the team to achieve overall assembly quality target as set by Management.
• Troubleshoot production issue and establish permanent solution to improve on processes and production yield.
• Ensure all NCR (Non‑Conformances Report) are close on time.
• Develop and foster quality awareness and teamwork among employees.
• Perform any other relevant and relates responsibilities that may be assigned from time to time as required by superior.

• Must be able to communicate fluently (written and verbal) in English and Malay language.
• Demonstrated ability to lead teams, manage projects, and influence stakeholders at multiple levels.
• Strong communication, analytical and decision‑making skills.
• Enthusiastic, cooperative, and positive behaviour.
• Strong knowledge in process validation planning and principle, process optimization, lean manufacturing, SPC, FMEA, DOE and other problem‑solving tools.
• Strong knowledge in Minitab software.
• Certifications such as Lean Six Sigma Green Belt/Black Belt, PMP, or safety certifications are an advantage.
• Minimum 5-8 years of experience in a manufacturing environment.
• Production engineering experience in manufacturing process.
• Worked in a lean manufacturing organization.
• Familiar with FDA requirement on medical device regulation.
• Bachelor’s degree in Engineering or other related field.
• Master’s degree in manufacturing related engineering field is an added advantage.

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Teleflex is an equal opportunities employer.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up‑front.