VP of Quality

EPM Scientific; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

EPM Scientific collaborates with a rapidly growing structural heart medical device company to seek a Vice President of Quality. The role will lead the Quality organization through commercialization and global expansion from Boston, MA, on-site.

The executive will set the Quality vision and strategy, oversee the QMS, and ensure compliance with FDA, ISO 13485, MDR, and MDSAP across development, manufacturing, supplier management, and post-market activities.

Qualifications

• Bachelor's degree in Engineering or related field.
• 15+ years of Quality experience in the medical device industry.
• 7+ years of leadership experience managing Quality teams.
• Experience with Class III medical devices and regulated environments.
• Strong knowledge of FDA QSR, ISO 13485, MDR, MDSAP, CAPA, Risk Management.
• Experience supporting development to post-market and regulatory approvals.
• Proven track record leading FDA inspections and notified body audits.

Responsibilities

• Develop and execute the global Quality strategy aligned with growth objectives.
• Provide executive oversight of the QMS ensuring regulatory compliance.
• Lead Quality functions: Quality Systems, Design Quality, Supplier Quality, Manufacturing Quality, Post-Market Surveillance.
• Partner with R&D, Regulatory, Clinical, Operations to support commercialization.

Skills

Leadership

Quality Management

Regulatory Compliance

Strategic Vision

Cross-functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related technical discipline

Job description

EPM Scientific is partnering with a rapidly growing structural heart medical device company that is advancing innovative therapies for patients with complex cardiovascular conditions. Following significant clinical progress, strong investor backing, and continued organizational growth, the company is seeking a Vice President of Quality to join its executive leadership team and lead the Quality organization through the next phase of commercialization and global expansion.

This executive will be responsible for setting the organization's Quality vision and strategy while ensuring compliance across product development, manufacturing, supplier management, post-market activities, and global operations. The VP of Quality will serve as a key business partner to executive leadership and play a critical role in scaling the company while maintaining a culture of quality and patient safety.

Responsibilities

Role: VP of Quality

Location: Boston, MA (On-site)

Salary: $250k-$350k

• Develop and execute the company's global Quality strategy in alignment with business objectives and long-term growth plans.
• Provide executive oversight of the Quality Management System (QMS), ensuring compliance with FDA, ISO 13485, MDR, MDSAP, and other applicable regulatory requirements.
• Lead and develop Quality functions including Quality Systems, Design Quality, Supplier Quality, Manufacturing Quality, Complaint Handling, and Post-Market Surveillance.
• Partner closely with Executive Leadership, R&D, Regulatory Affairs, Clinical, Operations, and Manufacturing teams to support innovation and commercialization efforts.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline.
• 15+ years of Quality experience within the medical device industry.
• 7+ years of leadership experience managing Quality organizations and cross-functional teams.
• Demonstrated success leading Quality organizations within Class III and highly regulated medical device environments.
• Strong expertise in FDA Quality System Regulations, ISO 13485, MDR, MDSAP, CAPA, Risk Management, Supplier Quality, and Design Controls.
• Experience supporting products from development through regulatory approval, commercialization, and post-market phases.
• Proven track record leading FDA inspections, notified body audits, and global compliance initiatives.
• Experience building and scaling Quality organizations within high-growth medical device companies.

Why This Opportunity?

• Executive leadership opportunity with direct influence on company strategy and growth.
• Lead and shape the future of the Quality organization on a global scale.
• Competitive compensation package including bonus, equity, and comprehensive benefits.
• Opportunity to make a meaningful impact on therapies that improve patient outcomes worldwide.