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Quality Manager
2 months ago
Summary
The Quality Manager assures conformance to all regulatory, laboratory, quality systems, internal and external customer requirements.
Job Responsibilities
· Maintain the employee training program including conducting and/or coordinating training and ensuring training files and documentation are current.
· Monitor the performance of Quality processes, personnel and methods to assure conformance to regulatory, quality system, internal and external customer requirements.
· Assess the effectiveness of processes, current specifications, test methods and personnel performance.
· Tracking and Trending to assess regulatory compliance of:
o Incident Reports, including investigations, OOS investigations, deviations, etc.
o Corrective Action / Preventative Action Reports
o Customer Feedback / Complaints
o Document Control
o Change Control
· Participate in customer audits (internal and external) and Regulatory Audits/Inspections.
· Provide overall guidance and leadership with the internal audit program.
· Inherent in the processes of Quality is the interpretation of requirements, and the need to use careful judgment to determine compliance. It is critical for the individual in this role to use sound judgment, and demonstrate consistent decision-making.
· Management includes, but is not limited to:
o development and implementation of inspection and operational procedures
o establish departmental operating budget, guidelines and practice
o monitor and maintain the department personnel and material resources to meet departmental commitments
o establish personnel performance criteria and provide the necessary training and resources to meet the performance goals and objectives
o provide evaluation and performance rating for departmental personnel
o provide methods to communicate the quality status of materials and processes to internal customers, management and external suppliers
o ensures that department operation and practices comply with OSHA, material handling and facility safety requirements
