Quality Engineer II

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.

• →Ensure that suppliers deliver quality parts, materials, and services.
• →Support Work with suppliers on quality issues observed during new product introduction.
• →Deliver & complete PPAP deliverables for new product & legacy product changes using process validation approach.
• →Evaluate supplier performance on periodic basis & take necessary action for continuous improvement.
• →Provide 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.
• →Collaborate with cross function team for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and ensure product quality and continuous improvement.
• →Ensure purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• →Collaborate with component engineers to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA, MSA, Control Plans and relevant quality tools and methodologies for new products and legacy product.
• →Prepare receiving inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
• →Support in supplier audit execution and ASL management.
• →Any other tasks assigned.

• Bachelor’s degree in engineering, Science, or Technical Discipline required and 5-8 years of quality systems experience. Experience in supplier management is added advantage.
• Good communication skills, both oral and written.
• Comfortable working with international and multi-cultural department and groups in different time zones.
• Timely & accurate delivery quality work.
• Ability to work well under pressure and maintain positive, enthusiastic attitude.
• Ability to work in a fast-paced environment.
• Eagerness to learn and expand responsibilities.

Nice to Have:

• Good interpersonal skills.
• Previous experience working with global team (Aerospace, Defence, Med device, automobile preferably).
• Exposure to FDA Quality System Regulation & ISO 13485 standard .
• Quality certification – CQE, CQA.
• Working knowledge of Standard, Guidance, and Regulations.
• Lean Six Sigma Yellow belt /Green Belt.

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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