Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
- Gratuity calculator
  
  Check your gratuity amount
- HRA calculator
  
  Check how much of your HRA is tax-free
- Salary hike calculator
  
  Check your salary hike
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 2K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Premium Employer

Medtronic

Compare

4.0

based on 535 Reviews

145 Medtronic Jobs

Senior Quality Engineer

India Medtronic Pvt. Ltd

4.0

based on 535 Reviews

5-12 years

Hyderabad / Secunderabad

1 vacancy

Senior Quality Engineer

Medtronic

posted 10d ago

Job Role Insights

Flexible timing

Key skills for the job

Medical Coding Biomedical Engineering Healthcare Regulatory Affairs Risk Management Medical Devices

+ 2 more

Job Description

A Day in the Life As a Senior Quality Engineer you will be a key member of the Medtronic Post Market Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety.

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.

Benefits Compensation

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 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 description

Prepare for Senior Quality Engineer roles with real interview advice