Medtronic Quality Engineer I - SHA - Post Market in Galway, Ireland
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 our Structural Heart Post Market Quality Department, we focus on completing investigations for complaints and returned devices, periodic trending of complaint data, evaluating negative trends and assessing risk to released products which aids in determining appropriate field actions.
We partner with cross-functional teams to perform thorough complaint investigations and with regulatory and customer quality experience management to prepare appropriate responses to regulatory queries for product registrations and other regulatory submissions. The department owns and maintains periodic safety update reports (PSUR) by collaborating with several cross-functional teams for applicable devices.
A Day in The Life Of:
1. Leads complaint investigations, conducts periodic trending of complaint data, evaluates negative trends, and assesses risk to released products which aids in determining appropriate field actions.
2. Collaborates with cross-functional teams like customer quality experience management, clinical affairs, medical safety, R&D engineering, and manufacturing to perform thorough complaint investigations.
3. Prepares appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team.
4. Partners with the design assurance team on risk analysis of new products by reviewing files such as product hazard analysis, DFMECA, post-market surveillance plan, risk management report, etc.
5. Develops solutions to unique issues with a wide range of difficulty. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation across functions and/or businesses which may cause redirection.
6. Prioritizes timely presentation of quality issues and escalates to leadership based on sound engineering, analysis & review for the success of the business.
Key Skills & Experience
1. Minimum of Level 7 bachelor’s degree required in Mechanical, Mechatronics, Manufacturing, Electronics & Biomedical Engineering or related discipline preferred.
2. Minimum of 1-year relevant direct Science/Engineering experience within a medical device environment.
3. Candidate must be a dynamic team player and can work effectively and proactively on cross-functional teams.
4. Candidate must be able to think critically and make sound decisions.
5. Demonstrated understanding of cardiovascular/implant procedures is an advantage.
6. Experience in a highly regulated industry, preferably implantable medical devices, is an advantage.
7. Knowledge of product development cycles including clinical and regulatory requirements is an advantage.
8. Experience in complaint handling or risk management would also be desirable.
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.
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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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