Quality Systems Lead

Mount Kemble Search Group; Portsmouth (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

Mount Kemble Search Group is seeking a Quality Systems Lead to maintain and improve the QMS to ensure compliance with FDA, cGMP, ISO, and internal quality requirements. The role partners closely with Manufacturing, Engineering, Operations, Supply Chain, and Regulatory teams to drive quality excellence and audit readiness.

The position leads CAPA, change control, document control, and quality records management; monitors quality metrics; and supports internal, supplier, customer, and regulatory

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; equivalent experience.
• 5+ years of quality experience in regulated manufacturing (medical devices, pharma, biotech, or combination products).
• Experience with CAPA, change control, deviations, nonconformances, document control, and quality systems management.
• Strong knowledge of cGMPs, FDA regulations, and quality system requirements.

Responsibilities

• Manage and enhance QMS processes and compliance programs.
• Lead CAPA, nonconformance, deviation, and root cause investigation activities.
• Support change control, document control, and quality records management.
• Monitor quality metrics, identify trends, and drive continuous improvement.

Skills

QMS management

CAPA

Regulatory compliance

Root cause analysis

Documentation control

Education

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

Tools

Electronic QMS platforms

Job description

The Quality Systems Lead is responsible for maintaining and improving the Quality Management System (QMS) to ensure compliance with FDA, cGMP, ISO, and internal quality requirements. This role partners closely with Manufacturing, Engineering, Operations, Supply Chain, and Regulatory teams to drive quality excellence, support audit readiness, and lead continuous improvement initiatives.

Key Responsibilities

• Manage and enhance Quality Management System processes and compliance programs.
• Lead CAPA, nonconformance, deviation, and root cause investigation activities.
• Support change control, document control, and quality records management.
• Monitor quality metrics, identify trends, and drive continuous improvement efforts.
• Coordinate and support internal audits, supplier audits, customer audits, and regulatory inspections.
• Ensure inspection readiness and timely closure of audit findings.
• Provide quality system training and guidance across the organization.
• Support supplier quality activities, risk management initiatives, and validation programs.
• Partner with cross-functional teams on new product introductions and operational improvement projects.

Qualifications

Required:

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical field, or equivalent experience.
• 5+ years of quality experience within a regulated manufacturing environment, including medical devices, pharmaceuticals, biotechnology, or combination products.
• Experience with CAPA, change control, deviations, nonconformances, document control, and quality systems management.
• Strong knowledge of cGMPs, FDA regulations, and quality system requirements.
• Excellent problem-solving, analytical, communication, and organizational skills.

Preferred:

• Experience with combination products, medical devices, or injectable drug delivery systems.
• Knowledge of FDA 21 CFR Parts 4, 210, 211, and 820, and ISO 13485.
• Audit leadership experience and familiarity with electronic QMS platforms.
• ASQ certifications (CQE, CQA, or similar) preferred.

Ideal Candidate

A collaborative quality professional with a strong background in regulated manufacturing who can effectively balance compliance requirements with business objectives. The ideal candidate excels in investigations, CAPA management, audit readiness, quality systems oversight, and continuous improvement initiatives while serving as a trusted cross-functional partner.