Sr. Quality Engineer

As a Sr. Quality Engineer at Medtronic, your primary responsibility will be to manage internal suppliers for released product engineering. You'll ensure all supplier qualification documents, performance records, and change controls adhere to company requirements. As a key member of the Medtronic Quality Engineering team, you will coordinate critical quality activities to uphold our high standards in healthcare innovation.

A Day in the Life

You will contribute to maintaining Medtronic's commitment to quality by:

• Ensuring that internal suppliers deliver quality parts, materials, and services.
• Supporting qualification activities of internal suppliers by verifying comprehensive documentation per Medtronic requirements.
• Monitoring internal supplier performance and taking necessary actions.
• Leading the Internal Change Control Board for the Ear, Nose, and Throat Medtronic Operating Unit, managing agendas, minutes, and action item follow-up.
• Issuing, collaborating on, and approving Supplier Change Requests (SCRs) for internal suppliers.
• Ensuring timely completion and appropriate approvals for internal supplier change requests.
• Establishing and maintaining Internal Quality Agreements and the Approved Supplier List (ASL) for internal suppliers.
• Ensuring internal suppliers meet the requirements of relevant Internal Quality Agreements.
• Leading any Corrective and Preventive Actions (CAPAs) related to Internal Suppliers processes.
• Providing input to Management Review on internal supplier performance and taking action as needed.
• Analyzing quality-related data as requested by Released Product Management (RPM) teams.
• Ensuring timely disposition of internal suppliers' Non-Conforming Material Reports (NCMRs), providing updates, and escalating as needed.
• Reviewing and approving NCMRs related to internal suppliers.
• Collaborating on and leading CAPAs as requested by RPM teams.
• Authoring or updating Standard Operating Procedures (SOPs) as requested by RPM teams.
• Working on post-market documents such as signal evaluations and Health Hazard Evaluations (HHE) as needed by RPM teams.

Required Knowledge, Experience & Skills

• Bachelor's degree in Engineering, Science, or a Technical Discipline.
• 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.
• 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.
• Good interpersonal skills.
• Previous experience working with a global team (Aerospace, Defense, Medical Device, Automobile preferred).
• ASQ Quality certification (CQE, CQA).
• Working knowledge of Agile MAP PLM system, Standards, Guidance, and Regulations.
• Hands-on experience with Minitab tools for statistical analysis.
• Exposure to auditing to FDA Quality System Regulation & ISO 13485.
• Lean Six Sigma Green Belt or Black Belt.

Nice to Have

• Previous customer-facing and/or project management experience.
• Ability to work effectively in a team environment and build strong working relationships.

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, boldly attacking 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 courage to engineer the extraordinary.