Quality Systems Manager

Gentuity•Sudbury, MA

About The Position

The Quality Systems Manager will be responsible for managing the Quality Management System (QMS) to ensure compliance with internal and external regulatory requirements, including FDA, ISO, MDD/MDR, and country-specific regulations. This role involves overseeing critical processes such as Document Control, Change Orders, CAPA, Complaints, SCAR, and Audit Findings. The manager will also lead supplier management, develop quality metrics, coordinate data collection for management reviews, and lead regulatory body audits, internal audits, and supplier audits. Additionally, the position entails leading Management Review, Quality Planning, and the site training program, tracking and reporting on Quality KPIs, organizing and leading meetings on KPIs and Trends, and coaching direct reports. A key aspect of this role is identifying and implementing QMS improvements to enhance efficiency and effectiveness, along with undertaking other assigned projects and tasks.

Requirements

Minimum of 7 years of experience in a Medical Device environment
3-5 years supervisory experience
Working knowledge in Internal and External auditing
Working knowledge in Corrective and Preventive action
Excellent verbal, written and presentation skills
Detailed organization skills
Team player with excellent communication skills
Knowledge of 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

Nice To Haves

Certified Internal Auditor preferred
Lean and Six Sigma Green Belt Certified preferred

Responsibilities

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.