Senior Quality Engineer

• Qualify suppliers according to company standards & management of ASL (Approved Supplier List) by Medtronic purchasing control compliance.
• Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology. Manage and release all PPAP deliverables (such as Control Plan, MSA, PFMEA, FAI etc.) in document control system.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic test methods.
• Collaborates with cross functional team 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 products.
• Provide technical assistance to supplier during product/ process qualification lifecycle, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Conduct audits to qualify suppliers for intended use for the business as needed.
• Work with suppliers to support SCAPA’s/NCR’s in adherence to company standards.

Required Knowledge and Experience:

• Bachelor’s degree in engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience. Experience in supplier management is added advantage.
• Strong communication skills, both oral and written.
• Ability to comprehend principles of engineering, physiology and medical device use.
• Comfortable working with international and multi-cultural departments 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 & accountability.
  Nice to have:
• Good interpersonal skills.
• Previous experience working with global team (Aerospace, Defense, Med device, automobile preferably).
• Previous customer-facing and/or project management experience is a plus.
• Ability to work effectively in a team environment and build strong working relationships.
• ASQ Quality certification – CQE, CSQP, CQA.
• Working knowledge of Agile MAP PLM system, Standard, Guidance, and Regulations.
• Hand on experience on Minitab tools to perform statistical analysis.
• Exposure in auditing to FDA Quality System Regulation & ISO 13485.
• Lean Six Sigma Green Belt or Black 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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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).