Sr. Quality Engineer

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 95000 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.

Medtronic is a 75-year global healthcare technology leader guided by a Mission to alleviate pain restore health and extend life delivering life-transforming technologies across 70 health conditions in cardiovascular neuroscience and surgical care.

Today our 95000 employees including 13500 engineers and scientists work across 150 countries helping treat more than 75 million patients each year. Innovation at Medtronic is disciplined and well-resourced with $2.7B USD invested annually in R&D 2700 patents and 174 active clinical trials all grounded in a deep commitment to quality ethics and putting patients first. As our business grows and we expand our operations in Malaysia were looking for individuals excited to join a team one where purpose meets potential to build careers that change lives.

In this exciting role as a Sr. 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 companys 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.

Main 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 companys 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.

Must Have: Minimum Requirements

• A university degree in engineering (biomedical chemical industrial biotechnology or related fields) is required and minimum of 4 years of relevant experience or advanced degree with 0 years of 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 skills/experience:

• 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.

TECHNICAL SPECIALIST CAREER STREAM:An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy:Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact:May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties.
Makes improvements of processes systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence:Communicates with senior internal and external customers and vendors.
Exchange information of facts statuses ideas and issues to achieve objective and influence decision-making.

Leadership and Talent Management:May provide guidance coaching and training to other employees within job area.
May manage projects requiring delegation of work and review of others work product.

Required Knowledge and Experience: Requires a Baccalaureate degreeand minimum of 4 years of relevant experience OR Masters degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

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.

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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. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.