Quality Systems Manager

Gentuity; Sudbury, Northern (MA, KY); On-site; USD 120,000 - 180,000; Full time

Job summary

Gentuity in Sudbury, MA is seeking an experienced QMS leader to ensure compliance with FDA, ISO, and global requirements. You will own document control, CAPA, supplier qualification, and major quality initiatives.

The role requires extensive experience in medical devices, strong audit capabilities, and a proven track record in training and leading teams. You will drive metrics, support management reviews, and coordinate cross‑functional improvement projects.

Qualifications

• 7+ years in a Medical Device environment with 3-5 years of supervisory experience.
• Experience with ISO 13485 and FDA Quality System Regulation.
• Auditing—internal and external, CAPA and corrective actions.
• Strong written and verbal communication and presentation skills.
• Detailed organizational abilities; team oriented with cross-functional collaboration.
• Lean and Six Sigma Green Belt certification preferred.

Responsibilities

• Ensure QMS compliance with FDA, ISO, and country requirements.
• Oversee Document Control system and Change Order processes.
• Lead CAPA, Complaints, SCAR, and Audit Findings activities.
• Manage supplier relationships and maintain Approved Supplier List.
• Develop and monitor Quality KPIs and support Management Reviews.
• Lead regulatory body audits and internal/supplier audits.
• Coordinate Training programs and Management Reviews.
• Organize monthly KPI meetings and communicate trends.
• Coach and develop direct reports; drive improvement initiatives.
• Drive efficiency improvements across the QMS.

Skills

Regulatory knowledge

Audit leadership

Quality systems

Leadership

Training

Communication

Education

Bachelor's degree in engineering or science

Master's degree in related field

Tools

PLM

ERP

MDM

MS Word

Excel

Teams

Project

Visio

Job description

Description

• Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements).


• Manage Document Control system, including the Change Order process.


• Manage the CAPA, Complaints, SCAR, and Audit Findings processes.


• Lead supplier management, including maintaining the Approved Supplier List for Critical/Crucial Suppliers and facilitating the re-evaluation of suppliers, including review of supplier data as appropriate.


• Own the development of Quality Metrics, and coordinate quality data collection and analyses for use in Management Reviews.


• Lead for regulatory body audits.


• Manage the Internal and Supplier Audit processes.


• Lead Management Review and Quality Planning.


• Lead and manage site training program.


• Track and report on company Quality KPIs.


• Organize and lead monthly company meetings on established KPIs and Trends.


• Coach, counsel, and train direct reports. Monitor performance and take appropriate action as necessary.


• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.


• Other projects and tasks as assigned.

Requirements

EXPERIENCE/SKILL REQUIREMENTS:

• Minimum of 7 years of experience in a Medical Device environment, 3-5 years supervisory experience.


• A working knowledge in the following areas:


• Internal and External auditing


• Corrective and Preventive action


• Excellent verbal, written and presentation skills


• Detailed organization skills


• Team player with excellent communication skills


• ISO 13485 and FDA Quality System Regulation


• Strong knowledge of Quality Systems programs including but not limited to Document Control, Record Control, Change Control, Training, and Device Master Record (DMR)


• Demonstrated experience in administration of electronic systems such as PLM, ERP, and MDM systems


• Strong communication skills, both written and oral; Ability to lead meetings and presentations


• Must be able to effectively communicate up/down and across different levels of the organization


• Demonstrated ability to work with MS Word, Teams, Excel, Project and Visio


• Demonstrated ability to independently troubleshoot issues with electronic systems


• Demonstrated experience in training users on systems and processes within an electronic environment


• Certified Internal Auditor preferred


• Lean and Six Sigma Green Belt Certified preferred

EDUCATIONAL REQUIREMENTS:

Bachelor’s with at least 7 years of experience. Or Master’s Degree with 6 years. 15+ years of experience may be considered in lieu of a degree for a candidate who can demonstrate the combination of experience, training, and education to be capable of successfully fulfilling all duties and responsibilities of the position.