Senior Quality Engineer

Medtronic plc; Kulim; On-site; MYR 120,000 - 210,000; Full time

Job summary

Medtronic plc in Malaysia invites applications for a Senior Quality Engineer to drive transfer of manufacturing processes to a new site. You will ensure ISO 13485 compliance and coordinate cross-functional teams across design, engineering, and supply chain.

Based on-site in Kulim, this role requires strong technical judgment, GMP knowledge, and willingness to travel for project transfers. You will mentor junior engineers and contribute to a robust QMS as part of a global team.

Qualifications

• Degree in engineering and at least 6 years of relevant experience.
• Experience in regulated industries (medical devices/pharma/biotech).
• Experience drafting and reviewing technical docs (protocols, reports, validations).
• Knowledge of ISO 13485 requirements.
• Good GMP understanding.
• Intermediate to advanced English, reading and writing technical documents.
• Clear verbal and written communication abilities; travel willingness.

Responsibilities

• Provide technical guidance to junior quality engineers during transfer.
• Develop and maintain quality standards for transferring products and processes per ISO 13485 and QMS.
• Collaborate with cross-functional teams to integrate quality requirements throughout transfer.
• Define inspection methods, sampling plans, and controls for transferred processes.
• Support TMV, IQ/OQ/PQ, and ensure regulatory and QMS compliance.
• Maintain risk management docs (PFMEA, control plans) for transfer and ramp-up.
• Coordinate readiness of equipment and tooling for qualification and start-up.
• Review nonconformances and drive CAPA closure.
• Maintain audit-ready records and support regulatory audits.

Skills

Quality engineering

ISO 13485

GMP knowledge

English (technical)

Education

Engineering degree

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year.

Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Together, we can change healthcare worldwide which is why we’re embarking on a new venture in Malaysia and want you to be a part the next generation of life-changing medical technology to patients worldwide by being a part of our next chapter of innovation in Malaysia. Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company. The ideal candidate will have a passion for the patients we serve and an unrelenting commitment to our new venture in Malaysia.

About the role

In this exciting role as a Senior Quality Engineer, you will be responsible for driving the transfer of manufacturing processes and products from our established facility to the new manufacturing site. While you will ensure that quality standards and protocols are effectively applied and maintained throughout the transfer process, aligning with ISO 13485 requirements and the company’s Quality Management System (QMS), you will have the unique and amazing opportunity to be a team player in a global team applying design flow down and transfer experience. This role requires strong technical judgment and ownership of quality strategy during manufacturing transfer. You will be reporting to the Senior Quality Manager and works closely within a cross-functional team including design and research, engineering, manufacturing, legal manufacturers, and supply chain to ensure successful and compliant manufacturing transfers. This position is based fully on-site at our new local facility. International travel of +25% may be required during the transfer project interacting with the sending site team and supporting key transfer activities at both sending and receiving sites.

Primary Responsibilities

• Provide technical guidance and mentorship to junior quality engineers and cross-functional teams throughout the transfer process.
• Develop, modify, apply, and maintain quality standards and protocols for transferring products and manufacturing processes, ensuring compliance with ISO 13485:2016 and the company’s Quality Management System (QMS).
• Collaborate with cross-functional teams including engineering, manufacturing, regulatory, supply chain, and suppliers to integrate quality requirements into all phases of the transfer plan, from process setup through production handover.
• Define and implement inspection methods, sampling plans, and quality controls for transferred processes, including in-process and final inspection stages.
• Support Test Method Validation (TMV), process validation activities (IQ/OQ/PQ), ensuring protocols, acceptance criteria, and documentation meet regulatory and QMS requirements.
• Ensure quality engineering activities for NPI manufacturing transfer are compliant with quality requirements, including traceability of DOTM, process validations, etc.
• Develop and maintain process risk management documentation (PFMEA, control plans) to identify, mitigate, and monitor process risks during transfer and production ramp-up.
• Coordinate readiness of manufacturing equipment, tooling, and inspection systems to support process qualification and production start-up.
• Work with the sending site and local teams to collect and analyze historical quality data, defect trends, and process capability information to proactively address known risks before production launch.
• Participate in readiness reviews, special builds, and verification activities to ensure process capability, product quality, and yield targets are met.
• Review and manage quality issues (e.g. nonconformances) during transfer builds, ensuring timely closure, root cause analysis, and escalation into CAPA when required.
• Ensure audit readiness by maintaining complete, accurate, and compliant records for validation, inspection, and risk management activities.
• Apply continuous improvement principles and implement structured problem-solving tools to drive issue resolution, waste elimination, and process optimization throughout the product transfer lifecycle.
• Focus on enhancing process stability, improving efficiency, and sustaining high-quality output post-transfer.
• Encourage a culture of First Time Quality at the Source, emphasizing preventive and predictive approaches to minimize defects and ensure compliance from the start.

Required Qualifications

• A university degree in engineering (biomedical, chemical, industrial, biotechnology, or related fields) is required and minimum of 6 years of relevant experience.
• Experience in regulated industries such as medical devices, pharmaceuticals, or biotechnology is necessary.
• Proficiency in preparing and reviewing technical documentation, including protocols, reports, and validations, is essential.
• Knowledge of ISO 13485 quality management system requirements must be demonstrated.
• A good understanding of Good Manufacturing Practices (GMP) is important.
• Intermediate to advanced English skills, especially for reading and writing technical documents, are needed.
• Clear verbal and written communication abilities are required.
• Experience with creating and maintaining SOPs, protocols, and technical reports is essential.
• Willingness to travel as per job requirements is necessary.
• Holding a valid passport for travel purposes is mandatory.
• Willingness to undertake extended overseas assignments of one month or more, if needed, is expected.

Preferred Qualifications

• Experience working with cross-functional teams such as production, quality, regulatory, and engineering adds value.
• Participation in at least one technology or process transfer project is expected.
• Participation in regulatory audits is considered beneficial.
• Knowledge of process validation activities including IQ/OQ/PQ is preferred.
• Experience in transferring production lines would be advantageous.
• Familiarity with product design documents, device master records (DMR), and design history files (DHF).
• Experience using quality management systems (QMS), managing CAPAs, and handling change control.
• Immediate availability or the ability to join within a short notice period is preferred.
• Previous experience collaborating with external teams from different countries.
• Cultural adaptability and experience working in multicultural environments will be valued.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

• Medtronic offers a competitive Salary and flexible Benefits Package.
• A commitment to our employees lives at the core of our values.
• We recognize their contributions. They share in the success they help to create.
• An incentive called the Medtronic Incentive Plan (MIP) is a short-term incentive.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people. We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R & D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will... Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.