Sr. Supplier Quality Engineer

Medtronic plc; Malaysia; On-site; MYR 80,000 - 120,000; Full time

Benefits offered by this job

Flexible benefits package

Short-term incentive plan

Job summary

Medtronic plc is seeking a Senior Supplier Quality Engineer in Kulim, Kedah, Malaysia. You will ensure that suppliers deliver quality parts and materials while monitoring and resolving supplier-related issues. The ideal candidate has a Bachelor's Degree in engineering and at least 4 years of relevant experience. Key responsibilities include qualifying suppliers, conducting regular audits, and providing technical guidance for quality compliance. This full-time position offers competitive compensation and benefits.

Qualifications

• 4+ years relevant engineering experience.
• Contribution to quality compliance for supplier engagement.
• Experience with quality management systems and CAPAs.

Responsibilities

• Ensure suppliers deliver quality materials and services.
• Evaluate supplier performance and oversee audits.
• Provide technical guidance in quality compliance.

Skills

Supplier performance monitoring and improvement

Communication and collaboration skills

Problem-solving and critical thinking

Knowledge of ISO 13485 and GMP

Experience in regulated environments

Technical documentation

Risk management

Education

Bachelor’s degree in engineering (biomedical, chemical, industrial, biotechnology, mechanical or related)

Tools

ISO9001 certification

Lead auditor certification

Six-sigma Green or Black Belt

PPAP and sampling plans

Job description

## Sr. Supplier Quality EngineerApplyremote type: Onsitelocations: Kulim, Kedah, Malaysiatime type: Full timeposted on: Posted 7 Days Agojob requisition id: R59481At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.# **A Day in the Life**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 95,000 employees, including 13,500 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, 2,700+ 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, we’re looking for individuals excited to join a team, one where purpose meets potential to build careers that change lives.**Responsibilities:**· Ensure that suppliers deliver quality parts, materials, and services.· Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.· Monitors parts from acquisition through the manufacturing cycle and communicate and resolves supplier-related problems as they occur.· Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.· Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.· Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.· Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.· Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.· Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.**Minimum Requirements:**· Bachelor’s Degree required in engineering (biomedical, chemical, industrial, biotechnology, mechanical or related) with 4+ relevant engineering experience**Desired Skills and Experience:**· Participation in at least 1 technology or process transfer project· Experience in regulated environments (medical devices, pharma, biotechnology)· Experience with technical documentation (protocols, reports, validations, etc.)· Knowledge of ISO 13485 and GMP· Understanding of change control and CAPA· Intermediate-advanced English (reading and writing technical documents)· Clear oral and written communication· Valid Passport· Willingness for travel for extended stays abroad (Up to 60 days at a time during 12 months time frame)• Certification in ISO9001 and ISO13485 (Ability to audit external suppliers)• Lead auditor certification, ASQ certified CQE. CQA is an asset.• Six-sigma Green or Black Belt is also an asset.• PPAP, sampling plans• Risk management• Problem-solving, critical thinking• Supplier performance monitoring and improvement• Knowledge of manufacturing processes and materials• Effective communication and collaboration skills• Experience working with multidisciplinary teams across countries (production, quality, regulatory, engineering)• Participation in regulatory audits• Process validation (IQ/OQ/PQ) experience• Technical documentation (SOPs, protocols, reports)• Transfer of production lines• Product design / DMR / DHF• Experience with QMS, CAPAs, change control**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 degree and minimum of 4 years of relevant experience OR Master's 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.# **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. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).