Sr Quality Engineer.

3 weeks ago

hyderabad, India Medtronic Full time

Careers that Change Lives

As a Senior Quality Engineer you will be a key member of the Medtronic Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through precise risk assessment and management.

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, 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.

Minimum Qualification 

·B E or B.Tech in Mechanical/Biomedical Engineering

·Minimum 5-8 years of quality engineering experience or equivalence and overall 8-10 years of experience

Key Technical Competencies 

·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

 Nice to Haves

·ASQ CQE, CQA, CSQE and/or CRE certification.

·ISO 9001 Internal Auditor / Lead Auditor Cerification

·ISO 13485 Internal Auditor / Lead Auditor Cerification

·Lean Six Sigma Green Belt or Black Belt

Your Answer

Together, we can change healthcare worldwide. At Medtronic, we push the limits ofwhat technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the

future.


Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

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