Education and/or Special Training • Bachelor’s degree (B.S.) or equivalent in related field.
• 6-10 years related experience or equivalent.

Job Description
• Directs and coordinates activities and operations of quality assurance department and staff. Providing the leadership, mission and vision for Quality organization.
• Developing, implementing and maintaining Quality Assurance and Regulatory Affairs systems and activities within FDA and international regulatory guidelines.
• May act as appointed Management Representative.
• Coordinates with other managers and associates to identify critical success factors, develop measurement systems, and implement continuous process improvement methodologies.
• Designs, develops, and implements comprehensive quality assurance programs.
• Maintains, enforces, and measures quality assurance processes.
• Defines and manages an end-to-end test environment including but not limited to selection of tools, methods, and process.
• Responsible for product performance and continuous improvement efforts.
• Reviews and evaluates services to correct deficiencies and formulate improvements.
• Assures on-time delivery of new projects; ensures product quality, performance, and conformity with company established specifications.
• Assists with the planning and implementation of new programs, services, and projects; monitors progress and evaluates results; recommends changes or other action as appropriate.
• Maintains and manages department budget.
• Reviews, analyzes, and implements technological changes to enhance performance and customer requirements.
• Hires, trains, supervises, motivates, and develops quality assurance staff; manages schedules and workflow.
• Maintains the Quality System: CAPA and Internal Audits.
• Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.
• Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.
• Coordinates Outside Inspection of the Quality System: FDA and Notified Body auditors.
• Coordinates Outside Inspection of the Quality System: FDA and Notified Body auditors.
• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Manages directly and/or through subordinate supervisors the activities of the Regulatory Affairs & Quality Assurance department.
• Develops and conducts staff training.
• Conducts performance/merit reviews.
• Coordinates priorities with associated managers.

Percent Travel Required 5%