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Sr. 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
- Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
- Subject matter expert in risk management for designated medical device products or platforms.
- Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
- Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements.
- Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies.
- Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator.
- Provide Quality support to facilitate resolution of product complaints and/or safety issues
- Previous experience working in a cross-functional team environment.
- Familiar with statistical software tools (Minitab)
- 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.
- Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
- Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices.
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.
- Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
- Good verbal and written communication skills
- Fair Knowledge in post market surveillance
- Familiar with DMAIC or DMADV(DFSS) methodologies
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 Quality Engineer roles with real interview advice
Top Medtronic Quality Engineer Interview Questions
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Q3. 1) What is latest defect, documents we prepare throughout SDLC and STLC 2) in automation: how to handle browser certificate errors in seleni ... read more
What people at Medtronic are saying
Rating based on 5 Quality Engineer
reviews
Anonymous · Production, Manufacturing & Engineering
in Hyderabad / Secunderabad
Likes
The best company I have ever worked in.
- Salary - Excellent
+6 more
Dislikes
Nothing to dislike.
Quality Engineer salary at Medtronic
reported by
58
employees
with 4-8
years exp.
₹6
L/yr - ₹16
L/yr
228%
more
than the average 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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