Responsibilities may include the following and other duties may be assigned.
Qualify suppliers according to company standards & management of approved supplier list per purchasing control compliance.
Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology.
Establish a process & ensures that suppliers deliver quality parts, materials, and services.
Provide pre-market quality engineering support to new product development (NPD) working in partnership with the 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.
Collaborates with 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.
Define product acceptance or receiving inspection requirements as required and associated test method validation for all internal Medtronic test methods. Work with suppliers on inspection and product acceptance.
Support audits to qualify suppliers for intended use for the business.
Support on SCAPA's/NCR's & supplier change requests as needed .
Must Have:
Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience.
Strong communication skills, both oral and written.
Ability to comprehend principles of engineering, physiology and medical device use.
Previous customer-facing and/or project management experience is a plus.
Comfortable working with international and multi-cultural department and groups in different time zones .
Accurate and delivers quality work, with a sense of urgency.
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 & accountablity .
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