At 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).

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here

Sr. Supplier Quality Engineer