Sr Supplier Qual Engineer

Job Description

Careers that Change Lives Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development & sustaining efforts of Medical Devices products at MEIC. As a member of the MEIC team, you will collaborate with the broader Medical Devices engineering team, clinical and commercial teams globally. You will enable design & development of medical devices/products and the associated infrastructure & capability building elements in close conjunction with the Global teams. ESSENTIAL DUTIES AND RESPONSIBILITIES Ensures that suppliers deliver quality parts, materials, and services. Qualifies 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 communicates 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 Global operations and supply chain team 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 project 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. PRINCIPAL WORKING RELATIONSHIPS The incumbent would work with the project team at MEIC Frequent interaction with team members from other disciplines, cross functional teams, to understand project requirements and to adhere to project deliverables & schedules. Possible interaction with clinicians, third-party vendors, contract manufacturers, and subcontractors. Bachelor s Degree in Mechanical Engineering or equivalent with 8 to 12 years of Relevant experience in supplier quality and qualification KNOWLEDGE, SKILL, AND ABILITY Strong understanding of medical device standards, guidelines and regulations per ISO 13485, ISO 14971 and Design controls ( 21 CFR Part 820). Knowledge on Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred. Knowledge on supplier process qualification and PPAP deliverables Ability to create, assess or review applicable product DHF deliverables such as Risk files, Sterilization reports, Bio-compatibility reports etc. along with support from relevant project stakeholders. Strong knowledge of Engineering fundamentals and application Able to effectively work with cross functional teams in a multinational matrix organization Superior written and verbal communication skills required. Good attitude and team player.Additional Information
• Posting Date: May 31, 2023
• Travel: No
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Keyskills :
engineering change managementiso 13485quality engineeringcapability building21 cfr