Sr Supplier 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 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 LifeThe Senior Supplier Quality Engineer is responsible for leading supplier quality activities to ensure purchased materials, components, and services meet Medtronic quality, regulatory, and business requirements. This role partners cross-functionally with suppliers, engineering, manufacturing, sourcing, and quality teams to drive supplier performance, resolve quality issues, support product lifecycle activities, and ensure compliance with applicable standards and regulations. The role also provides technical leadership in supplier qualification, process validation, risk management, and continuous improvement.

Responsibilities may include the following and other duties may be assigned.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

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.

Key Responsibilities

• Lead supplier quality activities across new product introduction, sustaining operations, product launches, and supplier changes.
• Qualify, monitor, audit, and requalify suppliers to ensure compliance with quality system and regulatory requirements.
• Manage PPAP for finished goods and components.
• Lead investigations into supplier-related nonconformances, material issues, escapes, and complaints, and drive CAPA using structured problem-solving tools.
• Partner with R&D, manufacturing, regulatory, and sourcing to support design transfer, process changes, and supplier transfers.
• Ensure supplier changes are properly assessed, validated, documented, and approved.
• Monitor supplier performance and drive improvements.
• Maintain compliance with Medtronic policies and applicable regulations, including ISO 13485 and China GMP.

Required Qualifications

• Bachelor’s degree in engineering, quality, life sciences, or a related technical field.
• Minimum 5 years of experience in supplier quality, manufacturing quality, quality engineering, or a related function in a medical device industry.
• Experience working with suppliers in manufacturing, component qualification, process validation, and change control.
• Strong knowledge of quality systems, risk management, CAPA, nonconformance management, and supplier controls.
• Experience conducting supplier audits and driving supplier corrective actions.
• Familiarity with medical device or other highly regulated environments.
• Strong analytical, communication, and stakeholder management skills.
• Ability to travel as needed to supplier or manufacturing sites.
• Good written and verbal English communication skills.

Preferred Qualifications

• ASQ Certified Quality Engineer, Certified Supplier Quality Professional, or Lead Auditor certification.
• Knowledge of statistical methods, process capability analysis, DOE, MSA, SPC, and validation principles.
• Experience with ERP, PLM, and quality management systems.
• Demonstrated success leading cross-functional projects and supplier performance improvement initiatives.

Working Conditions

• May require domestic and international travel.
• Ability to work across time zones and with global stakeholders.
• Work may include office, lab, manufacturing, and supplier-site environments.

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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Recruitment Fraud Alert 

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]. 

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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).