Vice President of Quality & Regulatory Affairs

Surf Search; Memphis (TN); On-site; USD 220,000 - 320,000; Full time

Job summary

Surf Search Inc. seeks a Vice President of Quality & Regulatory Affairs to lead quality management and regulatory compliance in a regulated medical device environment.

This executive will drive the QMS strategy, CAPA, audits, and customer-facing quality programs. The ideal candidate has 10+ years in quality roles within regulated manufacturing, deep ISO 13485 and FDA knowledge, and a track record of leading cross-functional teams that influence executive decisions and shape a strong quality

Qualifications

• 10+ years of progressive quality leadership in a regulated manufacturing environment.
• Experience in ISO 13485, FDA quality system requirements, and medical device regulations.
• Experience leading quality functions in contract/custom manufacturing environments.

Responsibilities

• Lead and continuously improve the Quality Management System (QMS) to ensure regulatory compliance and meet customer requirements.
• Oversee CAPA, nonconformances, root cause investigations, audits, and regulatory inspection readiness.
• Serve as the primary quality contact for customers, managing quality reviews, escalations, and compliance expectations.
• Partner with engineering and operations to support product development, process validation, manufacturing quality, and continuous improvement.
• Oversee regulatory activities and ensure quality systems remain aligned with evolving industry requirements.
• Lead, mentor, and develop the Quality & Regulatory team while promoting accountability and a strong quality culture.
• Contribute to executive-level decisions involving quality risk, customer relationships, operational performance, and business growth.

Skills

Quality leadership

Regulatory compliance

CAPA management

Root cause analysis

Auditing

Quality engineering

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Life Sciences

Job description

We are seeking a Vice President of Quality & Regulatory Affairs to lead quality and regulatory functions within a regulated medical device manufacturing environment. This individual will oversee the quality management system, ensure regulatory compliance, and build a culture of continuous improvement across the organization.

The ideal candidate brings progressive quality leadership experience in a contract manufacturing or custom manufacturing environment, with the ability to balance hands‑on quality oversight with executive‑level strategic leadership.

Key Responsibilities of the Vice President of Quality & Regulatory Affairs:

• Lead and continuously improve the Quality Management System (QMS) to ensure regulatory compliance and meet customer requirements.

• Oversee CAPA, nonconformances, root cause investigations, audits, and regulatory inspection readiness.

• Serve as the primary quality contact for customers, managing quality reviews, escalations, and compliance expectations.

• Partner with engineering and operations to support product development, process validation, manufacturing quality, and continuous improvement.

• Oversee regulatory activities and ensure quality systems remain aligned with evolving industry requirements.

• Lead, mentor, and develop the Quality & Regulatory team while promoting accountability and a strong quality culture.

• Contribute to executive‑level decisions involving quality risk, customer relationships, operational performance, and business growth.

Qualifications of the Vice President of Quality & Regulatory Affairs:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent experience.

• 10+ years of progressive quality experience in a regulated manufacturing environment, including at least 5 years in a leadership role.

• Strong working knowledge of ISO 13485, FDA quality system requirements, and applicable medical device regulations.

• Expertise in CAPA, nonconformance management, root cause analysis, auditing, inspection, calibration, and quality engineering.

• Experience leading quality functions in a contract manufacturing, custom manufacturing, or job shop environment.

• Ability to manage multiple customer requirements while maintaining consistent quality standards.

• Experience supporting or leading customer audits, regulatory inspections, or third‑party certification audits.

• Strong leadership and communication skills, with the ability to collaborate across engineering, operations, and executive teams.

Occupational Code: 11-3051.01 — Quality Control Systems Managers.