Quality Manager

Description:

Reporting into the site GM, the role of operations quality manager is to manage and provide direct and indirect supervision to skilled and intermediate-level professional employees performing diverse roles within the quality function or unit. Provide direction, coordination, and the tools needed to achieve and maintain the site Quality Management System and enable the achievement of quality objectives.

Additional responsibility in the role may be assigned and includes elements such as leadership and facilitation to cross-functional business processes that support the overall quality system.

• Supports generation of performance metrics for products and processes of moderate complexity, and drives the team to achieve Quality Goals set by management (i.e.: DPQL, Total Quality at Celestica (TQ@C)), following industry standards such as ISO, IPC, AS, TL

• Leads Quality Improvement Programs (QIP) in support of customer requirements and expectations that are considered medium in scale and moderately complex.

• Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.

• Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.

• Acts as company representative, developing and maintaining positive relationships with the device owners through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.

• Mentors and trains personnel in the practices of Quality management and Quality improvement (succession development)

• Resolves customer issues of moderate difficulty using quality tools: Root Cause Analysis and Corrective Actions that are effective and timely.

• Provides leadership and support in a variety of areas such as, analysis of nonconforming materials and customer return material authorizations. (RMA's), supporting customer and 3rd party audits, and the administration of Quality management (Documentation, Change Control, Corrective & Preventive Actions and Calibration)

• Supports new customer qualification and New product introduction with supplier assessments, First Article Inspections and oversee generation of product documentation for products / programs of moderate risk