Global Head of Quality & Regulatory Strategy

EPM Scientific; Boston (MA); Presencial; USD 250.000 - 350.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership

Quality Management

Regulatory Compliance

Strategic Vision

Cross-functional Collaboration

Educación

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

Descripción del empleo

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.