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Quality System Manager

3 months ago

Sudbury, Massachusetts, United States BlackTree Technical Group, Inc. Full time

Quality Systems Manager

SUMMARY OF PRIMARY DUTIES AND 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.

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

ISO 13485 and FDA Quality System Regulation

Certified Internal Auditor preferred

Lean and Six Sigma Green Belt Certified preferred

EDUCATIONAL REQUIREMENTS:

Bachelors with at least 5 years of experience.