Job Description
- Lead Risk Management per ISO14971 to guarantee the wellbeing and adequacy of item.
- Lead configuration surveys and chance administration audits as required amid different task stages.
- Work with R&D amid Electrical/Embedded improvements (Electrical and electronic equipment advancement and Software advancement) to give inputs w.r.t quality and wellbeing.
- Take an interest and direct DHF/DMR Reviews for Electrical/Embedded advancements
- Backing in V&V to guarantee item consistence, security, unwavering quality and adequacy.
- Backing to direct CSV/Process Validation as required.
Specialized Skill Set
- Pragmatic execution of Risk Management of Medical Device per ISO 14971.
- Involvement with Risk Analysis devices and methods.
- Experience on Medical Device Software Development Life Cycle Process (SDLC) IEC 62304.
- Experience on Medical Device Electrical/Electronic Hardware Development Life Cycle Process (HDLC).
- Comprehension of electrical and installed segment s working rule and usefulness
- Comprehension of different documentation required amid HDLC and SDLC.
- Commonality with IEC 60601-1 group of norms.
- Recognition with any fundamental programming language, installed programming and instruments.
- Comprehension of Quality Management Systems for Medical Devices. (ISO 13485, 21 CRF 820).
Company Profile:
Salary: Not disclosed
Industry: Textiles / Garments / Fashion / Accessories
Functional Area: Embedded / Chip Design
Role Category: Others
Employment Type: Full time
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