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