Medtronic
Location
Secunderabad | India
Job description
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
Job tags
Salary
