VP of Quality & Regulatory Excellence – Medical Devices

Surf Search; Memphis (TN); Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

Surf Search Inc. seeks a Vice President of Quality & Regulatory Affairs to lead quality and regulatory functions within a regulated medical device environment. The role balances hands-on oversight with executive strategy to drive continuous improvement.

The ideal candidate will have 10+ years of progressive quality experience in manufacturing, including at least 5 years in leadership, and deep expertise in ISO 13485, FDA QSR, and CAPA.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 10+ years of progressive quality experience in a regulated manufacturing environment, incl. 5+ years in leadership.
• Strong knowledge of ISO 13485, FDA QSR, and medical device regulations.
• Experience with CAPA, nonconformance management, root cause analysis, auditing, and inspections.
• Experience leading quality functions in contract/custom manufacturing or job shop settings.

Responsabilités

• Lead and continuously improve the QMS to ensure regulatory compliance and meet customer requirements.
• Oversee CAPA, nonconformances, root cause investigations, audits, and inspection readiness.
• Serve as the primary quality contact for customers and manage quality reviews and escalations.
• Partner with engineering and operations to support product development, process validation, and manufacturing quality.
• Oversee regulatory activities and ensure alignment with evolving industry requirements.
• Lead, mentor, and develop the Quality & Regulatory team and promote a strong quality culture.
• Contribute to executive decisions involving quality risk, customer relationships, and business growth.

Connaissances

Leadership

Regulatory affairs

Quality management

CAPA

Root cause analysis

Auditing

Process improvement

Customer engagement

Cross-functional collaboration

Quality engineering

Formation

Bachelor's degree in Engineering or Life Sciences

Description du poste

Surf Search Inc. seeks a Vice President of Quality & Regulatory Affairs to lead quality and regulatory functions within a regulated medical device environment. The role balances hands-on oversight with executive strategy to drive continuous improvement.

The ideal candidate will have 10+ years of progressive quality experience in manufacturing, including at least 5 years in leadership, and deep expertise in ISO 13485, FDA QSR, and CAPA.