QUALITY MANAGER - CAPA MEDICAL DEVICES

World class leader in medical device industry looking for Quality / CAPA management material. Candidate must be proficient with; 1. Serve as the Process Owner for both the Nonconformance (NC) and CAP System with the company. 2. Serve as a Subject Matter Expert in the NC/CAPA system. Coach internal customers in system execution. 3. Manage recurring NC/CAPA meetings in order to ensure timely completion of CAPA plans, generation of accurate records, and approval of CAPA activities. 4. At the regional level, support the organization in the creation of quality records pertaining to the nonconformance and CAPA system. 5. Analyze the current NC and CAPA metrics for analysis within or across product lines, facilities, suppliers, or functions. Ensure metrics are complete and accurate for management review. Initiate CAPA requests for adverse trends. 6. Audit all CAPA records to verify acceptability for external regulatory agency review. Ensure that corrective action is obtained for discrepant records. 7. Follow-up with all levels of the organization on past due NC and CAPA activities. Ensure that issues are escalated to the next level of management when necessary in order to ensure timely completion of NC/CAPA related activities. 8. Manage the approval of CAPA project phases, e.g. CAPA plan approval. 9. Ensure that all final quality records are archived in the documentation library. 10. Support internal and external regulatory audits to provide timely access to NC/CAPA related records. 11. Adhere to and ensure the compliance of the Company's Code of Conduct, Company policies, rules, procedures and housekeeping standards. Qualification Requirements- Minimum of 5 years experience working in a regulated environment, preferably in the medical device or pharmaceutical industries - Experience with Quality Management Systems (ISO 13485) and Medical Device Regulations (21 CFR 820) - Working knowledge of Risk Management and CAPA systems - Experience on project teams - Experience making systemic improvements to business process flows - Experience and/or ability to manage cross-functional meetings, train other employees and give short presentations - The ability to establish rapport with internal and external customers, peers, and employees in all departments - Proficiency in MS Office - Excellent organizational skills - Excellent written and verbal communication skills. Preferred Qualifications- Experience with Internet Applications, Q&MIS, Agile, and MRP - Working knowledge of the company's internal processes, procedures and policies - Cadence project management or equivalent project management training - Experience with applied problem solving techniques. ResponsibilitiesFor the North America region, manage the administration of the Nonconformance and CAPA Systems for the company. Conduct analysis of all CAPA activity to ensure timely completion of CAPA plans, generation of accurate records, and approval of CAPA activities. Manage the analysis of trends across products, facilities and functions. Coordinate regional Nonconformance and CAPA meetings, including the maintenance of all related quality records. Keywords:  Quality Manager Quality Assurance Manager Six Sigma Quality Engineer Quality Engineering