What You'll Work On
Management and development of Quality Systems Engineers.
Administer and lead Corrective/Preventive Action program for all MCS sites (five different locations).
Oversees the CAPA process from initiation to effectiveness review and ensure the CAPA process is compliant and effective and driving investigations to root cause.
Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
Provide influential peer leadership with international partner site to drive proactive quality improvements.
Identify Quality Initiatives and lead cross-functional teams to complete them.
Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge.
Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
Provides subject matter expertise, leadership and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.
Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organ.
Represent Quality Systems as required in support of cross-functional divisional projects. Identify Quality Initiatives and lead cross-functional teams to complete them.
Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
Produce and analyses trend metrics and reports and establishes further actions, as may be required.
Approves CAPA investigations and resolution plans, verifies completion of CAPA actions.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
