Amit Sewak
San Jose
Summary
Global quality and operations executive with 22 years of leadership experience in consumer products, medical devices, food & beverages and life sciences. Proven ability to develop and execute enterprise-wide quality global strategies that strengthen product integrity, vendor compliance, and customer satisfaction across global supply chains. Expert in global quality governance, risk management, regulatory compliance, continuous improvement, operational excellence and organizational transformation. Adept at leading and mentoring cross-functional teams, embedding consumer-first quality standards, and delivering measurable improvements in cost efficiency, product quality, and brand reputation.
Overview
13
13
years of professional experience
1
1
Certification
3
3
Associations
Work History
Vice President, Global Quality Management
RFXCEL
01.2019 - Current
- Established and led a global quality governance model, standardizing processes and documentation across the Americas, EMEA, and APAC regions.
- Directed quality integration into all global distribution operations, optimizing inbound/outbound inspection and returns management for 12 international sites.
- Implemented ISO 9001, ISO 27001, and GAMP-aligned QMS programs, achieving 40% reduction in quality-related issues and 28% improvement in product services availability.
- Built and mentored a global team of 45, fostering collaboration and accountability across all regions.
- Partnered with sourcing, supply chain, and product development leaders to embed quality by design and deliver consumer-focused outcomes.
- Chaired cross-functional steering committees, driving transformation in supply chain, QA, and operations, achieving $2M in annualized cost savings.
- Integrated three company acquisitions, aligning global compliance frameworks for improved risk management.
Director of Quality Management
RFXCEL
01.2015 - 01.2019
- Established enterprise quality and compliance function for global operations, setting industry benchmarks for SaaS and supply chain quality systems.
- Achieved ISO certifications in the US and EU and implemented OKRs/KPIs to drive cross-functional quality performance.
- Directed 30 annual audits and reduced defect rates by 30% through collaborative testing and supplier alignment.
Senior Manager Post Market Surveillance
ZOLL Medical
01.2013 - 01.2015
- Led post-market quality/compliance programs for Class III/II medical devices across multiple regions, achieving 100% on-time regulatory reporting and a 96% reduction in global complaint backlog.
- Hosted four international audits with zero findings, enhancing global compliance reputation.
Education
M.S. - Engineering Management
California State University East Bay
B.S. - Biochemistry
San Francisco State University
B.A. - Chemistry
San Francisco State University
Skills
- Global Quality Governance and Strategy
- Supplier Quality & Regulatory Compliance
- Cross-Functional Stakeholder Partnership
- Continuous Improvement & KPI Development
- Data Analytics & Risk Management
- Team Building & Leadership
- Change Management & Transformation
- ISO, GxP, EU MDR Implementation
- Post-Market Surveillance & Issue Escalation
- Complex Problem-solving
- Strategic planning
- Coaching and mentoring
- Client relationship building
Accomplishments
- Developed and led rollout of global QMS and compliance programs across 8+ international sites in under 12 months.
- Delivered a 35% reduction in supplier defects and standardized compliance monitoring across global supply chains.
- Built and led multi-regional teams of 80+ quality professionals across multiple sectors.
- Provided strategic executive counsel on quality risk, escalation, and market insights to C-suite leaders.
Certification
- Certified in Design Control, Process Control
- Six Sigma, Lean Methodologies (Applied Experience)
- AAMI Member, American Chemical Society Member
Timeline
Vice President, Global Quality Management
RFXCEL
01.2019 - Current
Director of Quality Management
RFXCEL
01.2015 - 01.2019
Senior Manager Post Market Surveillance
ZOLL Medical
01.2013 - 01.2015
B.S. - Biochemistry
San Francisco State University
B.A. - Chemistry
San Francisco State University
M.S. - Engineering Management
California State University East Bay
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