VP, Quality Assurance
Vice President, Quality Assurance
Location: Greater Philadelphia Area (Remote with 40-50% Travel to PA)
Overview
EPM Scientific is partnered with a global healthcare and medical technology organization to hire a Vice President, Quality Assurance. Our client is seeking an accomplished quality leader to provide strategic oversight across a portfolio of medical device products and manufacturing operations. This executive leadership role will be responsible for driving quality strategy, regulatory compliance, post-market quality activities, and continuous improvement initiatives while partnering closely with business, regulatory, engineering, and manufacturing leadership.
Key Responsibilities
- Provide strategic leadership for franchise Quality Assurance activities across the product lifecycle, ensuring compliance with global medical device regulations and quality standards
- Partner with business leadership to integrate quality and compliance requirements into product development, manufacturing, and lifecycle management activities
- Represent Quality within leadership forums, project teams, design reviews, and manufacturing site assessments
- Develop and monitor quality performance metrics, including CAPAs, complaints, audit findings, and field actions, to drive continuous improvement
- Provide executive-level reporting on quality performance, compliance risks, and key business initiatives
- Oversee post-market surveillance activities, including complaint handling, vigilance reporting, trend analysis, and field corrective actions
- Drive a strong quality culture and support harmonization of quality systems across manufacturing sites and operations
- Manage quality budgets, resource planning, supplier quality oversight, and compliance-focused initiatives
- Serve as a primary liaison during regulatory inspections, audits, and quality-related communications with health authorities
- Partner closely with Regulatory Affairs, Engineering, R&D, and Manufacturing to ensure compliance throughout product development and commercial operations
Requirements
- Bachelor's degree required; Master's degree preferred
- 10+ years of industry experience with at least 7 years of quality management leadership experience
- Strong background in medical device quality systems and global regulatory requirements
- Experience supporting product development, manufacturing, risk management, and post-market quality activities
- Proven ability to lead large, cross-functional organizations and influence executive stakeholders
- Strong strategic, operational, and people leadership capabilities
- Professional certifications are a plus
- Ability to travel as needed
Why This Role
- Executive leadership opportunity within a global medical device organization
- Broad influence across product development, manufacturing, quality, and regulatory functions
- Ability to shape quality strategy across a diverse product portfolio
- High visibility role with direct impact on compliance, business performance, and patient outcomes
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