Senior Quality Engineer
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.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.
- Good verbal and written communication skills including plan / report development.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation.
- Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports.
- Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
- Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance.
- Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR.
- Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis.
- Develop templates and trainings based on the quality system regulations, applicable standards and guidance.
- Independently review all deliverables to ensure compliance with development process and the standard.
- Deliver presentations to the QA organization on status and issues of assigned projects.
- Deliver trainings to departments outside of QA.
- Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
- Hands-on experience on EU MDR.
- Previous experience working in a cross-functional team environment.
- Hands-on experience on Risk Management, Design Controls for Medical Devices.
- Participate when appropriate in audits.
- Experience in collaborating with regulatory affairs teams for submission of safety reports.
Required knowledge and experience:
- B E or B.Tech in Mechanical/Biomedical Engineering
- Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Nice to Have:
- ASQ CQE, CQA, CSQE and/or CRE certification.
- ISO 13485 Internal Auditor / Lead Auditor Certification
- 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.
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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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).