Design Quality Assurance

6 days ago

Pune, India Cyient Full time

Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.

With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.

**Job Description**:
5 - 10 years of experience in product QA lifecycle, Sustenance product design LCM in medical device industry

Competency:
Quality Management ISO 1485
- Risk Management
- Design Controls and change Management
- Quality Assurance
- Quality Engineering
- Design Transfer / Supplier quality engineering

Hands on experience in Medical Device design and development projects per Quality

Management Systems (ISO 13485), Design controls (US FDA 21CFR 820. Part 30), and Risk

Management (per ISO 14971).

Coordinating with manufacturing team to develop the Process Validation testing (IQ,

OQ, PQ).

Application of ISO 14971, Medical Device-Application of Risk Management for the

various product families belonging to Hypo Disposable Medical Devices.

Updated Risk Management documents for the stand-alone products.

Interaction with Cross function teams regularly over the globe.

Skills & Experience

Customer Quality, Design Quality, ISO 13485:2003- Quality in Medical Devices, Management of Product & Facility quality systems, Medical Device Product Development Experience, Medical Technology & Healthcare, Quality Assurance, Quality Checking, Quality Complaints, Quality Consulting, Quality Control, Quality Management system, Quality Monitoring, Quality Services, Quality Training, Statistical Quality Control, Supplier Quality, - Clinical/ medical writing /regulatory writing experience - FDA (510K) submissions - Excellent communication skills both written and verbal, - Working experience in both Assay and Medical devices - Would have working experience in IVD industries

Cyient is an Equal Opportunity Employer.

Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.

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