Lead Quality Systems Specialist

Job description

PURPOSE AND SCOPE: Acts as a subject matter expert to support the organization with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality systems processes and standards for manufacturing and production. PRINCIPAL DUTIES AND RESPONSIBILITIES: Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. - A seasoned, experienced professional with full understanding of quality systems; resolves a wide range of issues in creative - ways. - Performs high level evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. - Trains other staff members - Responsible as back-up for manager when manager is not available Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. - Facilitates internal training on quality assurance requirements, processes, and procedures. - May perform audits and risk assessments. - Works on problems of diverse sco...