Job Description

Position Summary

Capstone Search Advisors is searching for a Quality Systems Specialist to oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, ISO 14971, EU MDR, and other applicable global medical device regulations.

This role will provide leadership in maintaining quality system processes, driving compliance, and fostering a culture of quality across the organization.

Key Responsibilities

• Manage and maintain the company’s QMS in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards/regulations.

• Lead the implementation, monitoring, and continuous improvement of quality system processes (Document Control, Training, CAPA, Nonconformance, Audits, Change Control, Complaints, Supplier Quality, etc.).

• Ensure timely and effective execution of Corrective and Preventive Actions (CAPA) and provide oversight of root cause investigations.

• Plan, coordinate, and lead internal audits; support external audits and regulatory inspections.

• Oversee document control and training programs to ensure compliance and employee competence.

• Partner with cross-functional teams (R&D, Manufacturing, Supply Chain, Regulatory, Clinical) to embed quality requirements throughout the product lifecycle.

• Monitor and analyze quality metrics and provide regular reporting to senior management.

• Ensure supplier quality management programs are compliant, including supplier qualification, audits, and performance monitoring.

• Serve as the SME (Subject Matter Expert) for QMS processes during regulatory inspections and customer audits.

• Mentor and develop quality team members, fostering a culture of compliance, accountability, and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field

• 3+ years of quality experience in the medical device or related regulated industry

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and related global quality system regulations.

• Experience leading audits (FDA, ISO Notified Body, MDSAP preferred).

• Proven track record of managing CAPA, nonconformance, change control, and complaint-handling systems.

• Excellent leadership, communication, and cross-functional collaboration skills.

• Proficiency with electronic QMS platforms (eQMS) strongly preferred.

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