Sr Quality Engineer - Q&R

As a Sr. Quality Engineer - Q&R at Medtronic, your primary focus will be on managing suppliers for both released product engineering and manufacturing transfers. You'll ensure all supplier qualification documents meet company requirements, leading robust supplier process qualifications and validations. As a key member of the Medtronic Quality Engineering team, you'll coordinate critical quality activities, ensuring the highest quality and reliable products for our customers.

A Day in the Life

You will play a vital role in ensuring product quality and compliance by:

• Qualifying suppliers according to company standards and managing the Approved Supplier List (ASL) per Medtronic's purchasing control compliance.
• Leading PPAP (Production Part Approval Process) execution with suppliers and ensuring robust supplier process qualification/validation through IQ, OQ, PQ methodologies.
• Managing and releasing all PPAP deliverables (such as Control Plan, MSA, PFMEA, FAI) in the document control system.
• Defining Receiving Inspection requirements and associated test method validation for all internal Medtronic test methods.
• Collaborating with cross-functional teams 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 for new and legacy products.
• Providing technical assistance to suppliers during the product/process qualification lifecycle to deliver quality parts, prevent defects, and ensure Medtronic provides the highest quality products.
• Conducting audits to qualify suppliers for intended business use as needed.
• Working with suppliers to support SCAPAs (Supplier Corrective Action/Preventive Action) and NCRs (Non-Conformance Reports) in adherence to company standards.

Required Knowledge, Experience & Skills

• Bachelor's degree in Engineering, Science, or a Technical Discipline.
• Minimum of 8 to 12 years of quality systems experience, with experience in supplier management being an 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 a positive, enthusiastic attitude.
• Ability to work in a fast-paced environment.
• Eagerness to learn and expand responsibilities and accountability.

Nice to Have Skills

• Good interpersonal skills.
• Previous experience working with a global team (Aerospace, Defense, Medical 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, Standards, Guidance, and Regulations.
• Hands-on experience with Minitab tools to perform statistical analysis.
• Exposure in auditing to FDA Quality System Regulation & ISO 13485.
• Lean Six Sigma Green Belt or Black Belt.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. We are committed to our employees, recognizing their contributions and providing resources to support you at every career and life stage.

About Medtronic

Medtronic leads global healthcare technology and boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people, leveraging talent, diverse perspectives, and guts to engineer the extraordinary.