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Medtronic
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Senior Quality Engineer

Senior Quality Engineer

Medtronic

8 - 12 years

20 - 25 Lacs

Hyderabad

Posted:2 days ago| Platform:

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Skills Required

Medical devices ISO 13485 Compliance Coding Quality engineering Healthcare market data Risk management Regulatory affairs Hazard analysis

Work Mode

Work from Office

Job Type

Full Time

Job Description

Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements.
Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.

Responsibilities may include the following and other duties may be assigned

Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
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.
Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports.
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.
Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis.
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.
Experience in collaborating with regulatory affairs teams for submission of safety reports.

Required Knowledge and Experience

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.

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Medtronic

Medical Equipment Manufacturing

Minneapolis MN

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Senior Quality Engineer