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Quality Engineer II
Medtronic
Hyderabad, IND
Full-time
Mid
Hybrid
Discovered Yesterday
IMDRFCAPANCMREU MDRISO 13485ISO 14971
Free
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Key Skills for This Role
IMDRFCAPANCMREU MDRISO 13485ISO 14971
Full Job Posting
Responsibilities may include the following and other duties may be assigned:
- Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
- Drafting and authoring PSUR or CER documents.
- 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.
- 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.
- Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports.
- Participate when appropriate in audits.
Required Knowledge and Experience
B E or B. Tech in Mechanical/Biomedical Engineering
Minimum 4 to 8 years of quality engineering experience.
Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR.
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, Risk Management, Design Controls for Medical Devices.
Familiar with ISO 13485, ISO 14971,21 CFR part 820, 21 CFR part 11 and EU MDR and product specific industry standards.
Understanding of post-market surveillance processes and adverse event reporting.
Knowledge of risk management principles and hazard analysis in the context of medical devices.
Good verbal and written communication skills including plan / report development.
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