What are the responsibilities and job description for the Quality Manager position at Centor?

Develop, implement, and maintain quality management systems (QMS) in compliance with cGMP, ISO 9001, ISO 15378, and other regulatory standards.
Lead quality assurance activities, including audits, inspections, and risk assessments.
Oversee the quality control process, including incoming raw materials, in-process checks, and final product inspections.
Ensure compliance with FDA regulations, including 21 CFR Part 820 and other applicable requirements.
Manage non-conformance investigations, CAPA (Corrective and Preventive Action) processes, and root cause analysis.
Develop and implement process improvements to enhance product quality and operational efficiency.
Collaborate with cross-functional teams, including production, engineering, and regulatory affairs, to maintain high-quality standards.
Provide leadership and training to quality team members, ensuring adherence to best practices.
Serve as the primary point of contact for regulatory agencies and customers regarding quality-related matters.
Maintain accurate documentation and reporting of quality metrics and compliance data.

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Centor

Millersburg, OH Full Time

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