Director of Quality

EPM Scientific; San Diego (CA); Vor Ort; USD 180.000 - 250.000; Vollzeit

Zusammenfassung

EPM Scientific partners with a medical device innovator to recruit a Director of Quality in San Diego, on-site. You will lead the Quality function across development, manufacturing and post-market activities, shaping QMS, risk management, and regulatory readiness.

Ideal candidates bring 10+ years in medical device quality, leadership experience, and strong knowledge of FDA QSR, ISO 13485, CAPA, and Design Controls. This role offers competitive compensation and benefits.

Qualifikationen

• 10+ years of quality experience in the medical device industry.
• Proven leadership of cross-functional teams.
• Strong knowledge of FDA QSR, ISO 13485, CAPA and risk management.

Aufgaben

• Lead and maintain the QMS in accordance with FDA, ISO 13485, and global regs.
• Partner with R&D, Regulatory, Manufacturing, Operations, and Supply Chain.
• Drive design assurance activities across product lifecycle: risk management, verification, validation, and design transfer.
• Oversee CAPA, complaint handling, nonconformance, internal audits, supplier quality, and post-market surveillance.
• Lead Quality strategy during development, commercialization and growth.
• Support regulatory inspections and audits by notified bodies and customers.
• Build, mentor and develop a high-performing Quality team.

Kenntnisse

Quality leadership

Regulatory knowledge

QMS implementation

CAPA management

Risk management

Design Controls

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Jobbeschreibung

EPM is partnering with an innovative medical device company developing cutting-edge wearable and connected technologies that are helping transform the management of chronic conditions. As the organization continues to scale, they are seeking a Director of Quality to lead and evolve the Quality function across product development, manufacturing, and post-market activities.

Responsibilities

Role: Director of Quality

Location: San Diego, CA (On-site)

Salary:$180k - $250k

EPM is partnering with an innovative medical device company developing cutting-edge wearable and connected technologies that are helping transform the management of chronic conditions. As the organization continues to scale, they are seeking a Director of Quality to lead and evolve the Quality function across product development, manufacturing, and post-market activities.

Responsibilities

• Lead and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulatory requirements.
• Partner with cross-functional stakeholders across R&D, Regulatory Affairs, Manufacturing, Operations, and Supply Chain.
• Drive Design Assurance activities throughout the product lifecycle, including risk management, verification, validation, and design transfer.
• Oversee CAPA, complaint handling, nonconformance management, internal audits, supplier quality, and post-market surveillance.
• Lead Quality strategy during product development, commercialization, and organizational growth.
• Support regulatory inspections, notified body audits, and customer audits.
• Build, mentor, and develop a high-performing Quality team.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 10+ years of Quality experience within the medical device industry.
• Prior leadership experience managing Quality teams and cross-functional initiatives.
• Strong working knowledge of FDA Quality System Regulations, ISO 13485, CAPA, risk management, and Design Controls.
• Experience supporting Class II and/or Class III medical devices.
• Experience within wearable devices, diabetes technology, connected devices, digital health, or combination products is highly preferred.
• Demonstrated success supporting products from development through commercialization.

Why This Opportunity?

• Join a rapidly growing organization in a high-growth market.
• Play a key role in bringing innovative wearable technologies to patients.
• Influence Quality strategy at both the operational and executive levels.
• Competitive compensation, bonus, equity, and comprehensive benefits package.