Ashish Shah
@ashishshah1
Senior Director of Quality with 20+ years leading global regulatory and enterprise quality strategy in medical devices.
United StatesWhat I'm looking for
I’m a results-oriented quality executive with 20+ years of progressive global leadership across Medical Devices and Consumer industries. I define and execute enterprise-wide quality strategies that support global growth, regulatory excellence, and customer experience.
Today, as Sr. Director of Quality for Instruments and Reagents at Becton Dickinson, I develop and run quality strategy across the product lifecycle, including post-market activities. I’m accountable for product quality, compliance risk management, field actions, and timely escalation of critical quality issues to executive leadership.
Across my Director of Quality roles in EMEA and Asia Pacific, I built and led global quality organizations across US, EMEA, and APAC. I’ve driven measurable outcomes—20–40% reductions in complaints, Quality Notifications, and COPQ improvement—and consistently prepared for and completed external audits with zero major and critical non-conformance.
My deep expertise spans FDA, ISO 13485, EU MDR/IVDR, design assurance, manufacturing quality, validations, supplier ecosystems, CAPA, and non-conformance management. Trained as a Six Sigma Green Belt and experienced in design control and design history file remediation, I partner with R&D, Regulatory Affairs, Manufacturing, and Supply Chain to accelerate innovation while keeping compliance and quality culture strong.
Experience
Work history, roles, and key accomplishments
Developed and executed quality strategy for instruments and clinical reagents platforms, establishing key driver goals to ensure compliance throughout the product lifecycle and post-market activities. Led a global quality team of 90+ associates and supported regulatory continuity during manufacturing transfers to 5 sites.
Accountable for strategic quality plans and key driver goals for the LifeScience segment across EMEA, leading multiple manufacturing facilities. Established a quality culture that reduced complaints, quality notifications, and COPQ by 20–40%, and completed multiple external audits at EU sites with zero major/critical non-conformance.
Oversaw quality for multiple manufacturing facilities in Singapore, China, and India for BD Medication and Procedural Solution and bioscience businesses. Led regional strategic quality planning and supplier quality improvements, while preparing FDA/ISO/government audits with zero major/critical non-conformance and meeting quality metrics for complaints, audits, QNs, field actions, CAPA, deviations
Managed quality engineering resources supporting new product development and product maintenance, and presented management reviews to the business president for Hypodermic/Anesthesia platform issues and updates. Directed complaint and CAPA focus on business-critical matters, including root-cause corrective actions and health hazard analysis for field action/recall activities.
Education
Degrees, certifications, and relevant coursework
University of Massachusetts Lowell
Master of Science, Plastics Engineering
1997 - 1998
Earned an MS in Plastics Engineering from the University of Massachusetts Lowell (Jan 1997 to Jun 1998).
MIT, Pune
Bachelor of Science, Polymer Engineering
1993 - 1996
Earned a BS in Polymer Engineering from MIT in Pune, India (Aug 1993 to May 1996).
Gujarat Board
Associate of Arts, Mechanical Engineering
1990 - 1992
Earned an AA in Mechanical Engineering from Gujarat Board (Aug 1990 to Jun 1992).
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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