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Quality/Senior Quality Manager

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$140,000  •  Needham, MA
•  Direct Hire
•  Job Number:258324
•  Posted:12/20/2024

Direct Hire

130-150K plus bonus

Education Requirements:
Bachelor’s degree in science or engineering.
Advanced degree in science, engineering, or business a plus

The Quality/Senior Quality Manager will ensure all design, manufacturing, and distribution of Advanced Instruments products produced at the Norwood site are in compliance with regulatory requirements, MDSAP/ISO standards, and GMP as applicable. 

Experience Requirements:
Extensive knowledge of ISO 13485, ISO 9001, FDA QSR, IVDR, and applicable product safety standards.

10+ years of quality systems experience supporting medical devices including specific experience with in vitro diagnostics (IVD); additional applicable experience is a plus.

5+ years of direct management experience, including performance management and staff development.
Experience managing ISO/MDSAP and customer audits and/or regulatory inspections.

Proficiency in utilizing electronic QMS software and Business Intelligence tools.

Strong organizational, written and verbal communication skills.

Requirements

Essential Functions:
Directly manage Quality Assurance (QA) and Quality Control (QC) teams to provide support across all functions at Advanced Instruments.

Lead the site’s Quality Management System, including CAPA, NCMR, Waivers, Complaints, Audits, and Management Review processes.

Coordinate global QMS activities with other Advanced Instruments site Quality teams.

Work cross-functionally for new product development and ensure the adequacy of requirements, specifications, test protocols, and reports.

Provide support for reviewing product/manufacturing process changes by assisting with the requirements changes, specification changes, risk management, and verification and validation to ensure internal design control procedures are complied with and external standards are followed.

Assume the role as a QMS expert within the organization and stay current with new and changing regulatory requirements within the industry

Establish and promote a strong culture of Quality in the organization focused on continuous improvement.

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