VP, Quality Assurance

EPM Scientific; Philadelphia (Philadelphia County); Remote; USD 230,000 - 320,000; Full time

Job summary

EPM Scientific is partnering with a global medical technology organization to recruit a Vice President, Quality Assurance. This executive will shape quality strategy across medical device products and manufacturing operations, drive regulatory compliance, post-market activities, and continuous improvement while partnering with senior leaders.

Based in the Greater Philadelphia Area with remote work and 40-50% travel to PA, this role requires strong cross-functional leadership, strategic vision,

Qualifications

• Bachelor’s degree required.
• Master’s degree preferred.
• 10+ years of industry experience with at least 7 years of quality management leadership experience.

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.

Skills

Quality leadership

Regulatory compliance

Quality systems

Cross-functional leadership

Executive communication

Education

Bachelor's degree

Master's degree

Job description

Location: Greater Philadelphia Area (Remote with 40-50% Travel to PA)

Vice President, Quality Assurance

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