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Senior Quality Engineer
Medtronic
posted 6d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Responsibilities may include the following and other duties may be assigned
- Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
- 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.
- 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.
- Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards.
- 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.
- Understanding of post-market surveillance processes and adverse event reporting.
- Knowledge of risk management principles and hazard analysis in the context of medical devices.
- Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.Familiar with DMAIC or DMADV(DFSS) methodologies.
- 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.
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 90,000+ passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD 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.
Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD 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
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Senior Quality Engineer roles with real interview advice
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What people at Medtronic are saying
Rating based on 3 Senior Quality Engineer
reviews
Anonymous · Research & Development
in Hyderabad / Secunderabad
Likes
Competitive package
- Salary - Good
+2 more
Dislikes
Company's culture changing to corporate culture full of tracking and ppts..
- Work satisfaction - Poor
+2 more
Senior Quality Engineer salary at Medtronic
reported by
73
employees
with 6-12
years exp.
₹12
L/yr - ₹27
L/yr
138%
more
than the average Senior Quality Engineer Salary in India
View more details
What Medtronic employees are saying about work life
based on 536 employees
Flexible timing
Monday to Friday
Within country
Day Shift
Medtronic Benefits
Health Insurance 
Job Training 
Work From Home 
Soft Skill Training 
Free Transport 
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Medtronic Hyderabad / Secunderabad Office Location
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G-1, Ground Floor, Shop No.8-2-248A, Maharishi House, Rd Number 3, VST Colony, Banjara Hills, Hyderabad, Telangana
Hyderabad
500034
500034
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