At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as senior quality engineer , your primary focus responsibility will be managing internal suppliers for released product engineering and ensuring suppliers qualification documents , performance records , change control etc are in accordance with the company requirements . You will be a key member of the Medtronic quality engineering team and responsible for coordinating

Responsibilities may include the following and other duties may be assigned:

• Ensures that internal suppliers deliver quality parts, materials, and services.

• Support the qualification activities of internal suppliers by ensuring that the internal supplier profile contains all the required information and documentation per Medtronic requirements

• Monitors internal suppliers’ performance and take action as needed

• Leads the Internal Change Control Board for the Ear, Nose and Throat Medtronic Operating Unit. Responsible for the agenda, meeting minutes, and follow up on action items

• Issues, collaborates and approved Supplier Change Requests (SCRs) for internal suppliers and other as needed.

• Ensures that the change request from internal suppliers are completed timely and have the appropriate approvals

• Responsible that the Internal Quality Agreements are established and maintained as required

• Ensure that the ASL (Approved Supplier List) for the internal suppliers is established and maintained as required

• Ensures that the internal suppliers are meeting the requirements of the relevant Internal Quality Agreement

• Leads any CAPAs that are related to Internal Suppliers processes

• Provide input to Management Review on the internal suppliers' performance and takes action as needed

• Analyzes quality related data as needed by the RPM teams

• Ensures timely disposition of internal suppliers NCMRs, provides regular updates and escalates accordingly

• Reviews and approves NCMRs related to internal suppliers and as required and needed by the RPM teams.

• Collaborates on and leads CAPAs as requested and needed by the RPM teams

• Authors or updates SOPs as requested and needed by the RPM teams

• Works on post-market documents as requested and needed by the RPM teams. This can include but not limited to signal evaluations and HHE (Health Hazard Evaluations)

Required knowledge, experience & skills :

• 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.
• 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 & accountability .
• 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, 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.

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.

About Medtronic

We lead global healthcare technology and boldly attack 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. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here