Improver

Dharmesh Rupareliya

Sr. Director, Global Quality @ BD | Helping medical device companies improve product quality and customer experience.

San Diego County, California

* 20 years of device engineering experience in Medical Device New Product Development with roles spanning across all functions of quality assurance.
* Experienced in Post-market surveillance, complaint handling, failure analysis, field actions, and CAPA process, internal and regulatory audits
* Expertise in assembling and leading cross-functional teams for Risk Analysis, Design and Process FMEA, Manufacturing process and Line validation, Software and Product qualification,
* Proven track record of managing teams and successful qualification of 6+ multi-component medical device systems, experienced in collaborating with geographically dispersed teams and contract manufacturers
* Successfully executed continuous improvement projects using See it - Own it - Solve it - Do it (SOSD) methodology
* Experienced in managing compliance with all major medical device regulatory standards including FDA 21 CFR 820, MDD 93/42/EEC, IEC 60601 and collaterals, ISO 13485, IEC 62304, and ISO 14971
* Experienced in project management activities involving budgeting, scheduling, resource planning, and maintaining Design History File (DHF)

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Experience:

• Senior Quality Systems Manager (Fresenius Medical Care North America)
• Sr. Director, Quality Assurance (CytoVale)
• Lead Quality Assurance Roles (Edwards Lifesciences)
• Sr. Director, Global Quality (BD)
• Lead Quality Assurance roles (Medtronic)

Skills: