Quality Enginr II

Medtronic

4 - 8 years

4 - 5 Lacs

Hyderabad Telangana India

Posted:7 months ago

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Job Description

Must Have

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.

Minimum Qualification

B E or B.Tech in Mechanical/Biomedical Engineering
Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience

Key Technical Competencies

Understanding of post-market surveillance processes and adverse event reporting.
Knowledge of risk management principles and hazard analysis in the context of medical devices.

Nice to Haves

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

Skills Required

quality standards manager quality assurance production control manager technology healthcare inventory control process quality talent management individual contributor

Work Mode

On-site

Job Type

Full Time

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