Quality System Manager

3 weeks ago

Sudbury, 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:

Bachelor’s with at least 5 years of experience.

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