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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

Product management Graphics Accessories Software design Minitab ISO 13485 Hardware design Healthcare Product design PFMEA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Capable of mentoring junior quality engineers in providing quality engineering support.

Responsibilities may include the following and other duties may be assigned

Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Hands on experience with tools package release process for both Software & Hardware tools/accessories Review non product/off-the shelf tools for products Experience in software or hardware design transfer process for tools or products Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, FDA Quality System Regulations, EU MDR and inhouse Standards. Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance. Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA Ensure successful transfer of new products/tools to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Review Design History Files and Technical Files for conformance to applicable requirements. Participate when appropriate in audits Ensures applicability to SOUP / OTS validations in the product development Participate and provide input to training on department / procedures and policies Hands-on experience on Software Risk Management, Design Controls. Develop templates and training based on the quality system regulations, applicable standards and guidance. Independently reviews all SW deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver training to departments outside of QA. Previous experience working in a cross-functional team environment. Provide Quality support to facilitate resolution of product complaints and/or safety issues Provide support to the Regulatory Department in writing technical submissions.

Required Knowledge and Experience

B E or B. Tech
Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab, Stat Graphics) Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Strong in software design and development, software verification and validation activities Computer literate and experience with PCs, networks, applications, software development life cycle Travel may be required Knowledge in cybersecurity

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Medical Equipment Manufacturing

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Senior Quality Engineer