Design Quality Engineer
This Design Quality Engineer role at Bean HR Consulting focuses on ensuring software and digital health products meet rigorous regulatory, safety, and compliance standards. The hire will partner with NPD teams to execute risk management, review DHF documentation, and oversee software verification and validation activities. Ideal candidates bring significant experience with IEC 62304, ISO 14971, and medical device software lifecycles. The position involves close cross-functional collaboration with R&D, regulatory, and quality teams in Gurugram.
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Experience
4-8 years
Function
Quality Assurance
Work mode
Onsite, India
Company
Tier 2
What you will work on
This Design Quality Engineer role at Bean HR Consulting focuses on ensuring software and digital health products meet rigorous regulatory, safety, and compliance standards. The hire will partner with NPD teams to execute risk management, review DHF documentation, and oversee software verification and validation activities. Ideal candidates bring significant experience with IEC 62304, ISO 14971, and medical device software lifecycles. The position involves close cross-functional collaboration with R&D, regulatory, and quality teams in Gurugram.
TAL's take
Role is well-defined and scoped for a niche regulatory domain, but company brand is unknown.
Very clear, specific responsibilities and required regulatory standards listed for a specialized quality role.
Must haves
- Bachelor’s degree in Computer Science or related field
- 4–8 years of experience in software quality engineering
- Hands-on experience with IEC 62304
- Strong understanding of ISO 14971, ISO 13485, 21 CFR 820
Tools and skills
Nice to have: programming languages, embedded systems, software lifecycle tools.
About the company
Unfamiliar company in a consulting context, assigned mid-tier.
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