Sr. Quality Enginr

Medtronic

5 - 12 years

5 - 12 Lacs

Hyderabad Telangana India

Posted:7 months ago

Apply

Job Description

A Day in the Life

Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards.
Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.

Must Have

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, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and other relevant industry standards during product development and changes.
Participate on cross-functional teams to develop product risk management file for software and non software products (risk management plan, risk assessments, Hazard Analysis, DFMEA, and risk management report).
Strong in software risk management, software design and development, software verification and validation activities
Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies.
Provide Quality support to facilitate resolution of product complaints and/or safety issues
Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices.
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.
Good verbal and written communication skills

Minimum Qualification

B E or B.Tech in Computer science/Mechanical/Biomedical Engineering
Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience

Nice to Haves

ASQ CQE, CQA, CSQE and/or CRE certification.
ISO 9001 Internal Auditor / Lead Auditor Certification
ISO 13485 Internal Auditor / Lead Auditor Certification
Lean Six Sigma Green Belt or Black Belt

Skills Required

computer science medical devices minitab cre healthcare product design risk management biomedical

Work Mode

On-site

Job Type

Full Time

More Jobs at Medtronic

Sales Representative II - Endevenous - Delhi

Delhi, delhi

6.0 - 6.0 yrs

Salary: Not disclosed

Sales Representative II - Endevenous - Delhi

Delhi, delhi

6.0 - 6.0 yrs

Salary: Not disclosed

Software Engineer II

Pune

2.0 - 7.0 yrs

INR 17 - 19 Lacs

Co-op/Apprentice (Non-Tech)

Kolkata, Mumbai

Experience: Not specified

INR 6 - 9 Lacs

Reliability Engineer II

Hyderabad

8.0 - 12.0 yrs

INR 22 - 25 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.