Quality Systems Lead — Regulatory Readiness & QMS Ownership

Guided Search Partners; Fairfield (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

Guided Search Partners is supporting a search for a Quality Systems Manager in Fairfield, New Jersey to oversee the Quality Management System. This role will focus on compliance with ISO standards and regulatory expectations while driving improvements in quality processes.

The ideal candidate will have 10+ years of experience in medical device manufacturing, a strong understanding of QMS management, and the ability to lead teams effectively. Ownership of quality systems and proactive contributions to regulatory readiness are key aspects of this position.

Qualifications

• 10+ years of experience in medical device manufacturing quality systems.
• Direct ownership of QMS processes and managing audits.
• Hands‑on FDA site registration experience preferred.

Responsibilities

• Lead and maintain the Quality Management System focused on compliance.
• Support ISO 13485 and ISO 9001 quality system requirements.
• Drive continuous improvement initiatives within the quality system.

Skills

Medical device manufacturing experience

Strong communication skills

QMS process ownership

Continuous improvement

Education

Bachelor’s degree in Engineering, Quality, or related field

Tools

ISO 13485

ISO 9001

21 CFR Part 820

Job description

Guided Search Partners is supporting a search for a Quality Systems Manager in Fairfield, New Jersey to oversee the Quality Management System. This role will focus on compliance with ISO standards and regulatory expectations while driving improvements in quality processes.

The ideal candidate will have 10+ years of experience in medical device manufacturing, a strong understanding of QMS management, and the ability to lead teams effectively. Ownership of quality systems and proactive contributions to regulatory readiness are key aspects of this position.