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Senior Quality Assurance Manager

Company: Oxenham Group
Location: Nashville
Posted on: August 7, 2022

Job Description:

Title: Sr. Manager Quality SystemsLocation: Nashville, TNOur client is a medical device manufacturer with a focus on dental care. The company is hiring a Sr. Manager of Quality Systems to support the enhancement of their current system. The ideal candidate is a servant leader with 8+ years of quality engineering experience and 3 years of management experience. This role has to opportunity to become the Director within 12-18 months.Responsibilities:--- Create and generate a departmental culture of Quality and drive quality culture initiatives--- Manage and build the quality team that establishes and maintains the quality system and activities to assure conformance to GMP and applicable quality standards--- Drive the implementation, deployment, and maintenance of the quality management system.--- Manage the activities related to quality risk management programs and facilitate risk management discussions.--- Manage site supplier quality process and manage quality agreements.--- Manage internal audit systems including follow up and resolution of audit findings.--- Host Regulatory Inspections as well as third party audits.--- Direct and establish periodic Quality Management Review.--- Establish site quality metrics and associated process for tracking and reporting.--- Drive the implementation, deployment & maintenance of a GMP Document Control, Learning and Training Program.--- Maintaining GMP compliance related activities with current and new regulations, standards, and best practices.--- Provide compliance and quality system training for the organization.--- Partner with peers in multiple functions to ensure awareness and maintain alignment between regulatory activities, customer needs and business objectives.--- Manage and lead the quality department and all aspects of the personnel process such as hiring, onboarding, mentoring, coaching, performance management and employee development.--- Contribute to a monthly departmental Quality Report.Qualifications:--- 8+ years of experience within medical device manufacturing--- 3+ years of experience within quality leadership--- Experience hosting external audits--- Extensive understanding of ISO 13485, MDSAP, and CFR Part 820--- Experience with direct reports

Keywords: Oxenham Group, Nashville , Senior Quality Assurance Manager, Executive , Nashville, Tennessee

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