Quality Engineer II

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

Responsibilities may include the following and other duties may be assigned

Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
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) Assess complaints for completeness and determine need for investigation or signal evaluation Analyse complaint data to identify safety signals or adverse trend patterns for signal detection & evaluation. Conduct statistical evaluation to determine the significance of identified signals Draft signal evaluation reports and adverse event reports (e.g., MDRs) according to FDA, EU MDR, ISO and other global regulatory standards Liaise with engineering, manufacturing, regulatory, clinical, and quality teams to support investigations and CAPA actions Escalate high-risk signals for management review and regulatory notification Ensure investigations and reports comply with 21 CFR 803/820, FDA MDR, ISO 13485, ISO 14971, EU MDR, etc. Support audits, document reviews, and CAPA follow-through as needed Good verbal and written communication skills including plan / report development.

Required Knowledge and Experience

B E or B.Tech in Mechanical/Biomedical Engineering

Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience
Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices.

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.