Senior Quality Engineer

Senior Quality Engineer

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.

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.

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

• Reviews and approves NCMRs as required and needed by the ENT teams.
• Reviews and approves process and design changes as needed
• Collaborates on and leads CAPAs as requested and needed by the ENT teams
• Authors or updates SOPs as requested and needed by the ENT teams
• Supports the completion of test method validations
• Works on post-market documents as requested and needed by the ENT teams. This can include but not limited to signal evaluations and HHE (Health Hazard Evaluations)
• Supports Risk Management File remediation activities as needed
• Performs Risk Management periodic reviews as needed as well as complaints risk assessments
• Supports PSUR/CER activities as needed
• Supports the MDR reportability decision adjustments by performing complaints searches for all products, review for malfunction related serious injuries, and any other activities as identify by the ENT teams.

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 & 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. Proficient in the use of Root Cause Analysis Tools Knowledge and application of risk management processes and applicable standards (i.e ISO14971) Experience with statistical techniques

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.

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.

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.