Under minimal direction, this position is responsible for strategic oversight of quality and operational excellence across the enterprise. Collaborates to build strong relationships, enable business results, and ensure improved performance. Models behavior that exemplifies the pursuit of perfection in everything we do. Provides regulatory and compliance expertise and guidance. Develops a team of quality professionals to support our mission through living the RITE values.
DUTIES AND RESPONSIBILITIES:
- Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
- Assures quality customer service to all customers.
- Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.
- Hires, supervises, trains, develops, and evaluates performance of assigned staff. Identifies and effectively resolves employee issues.
- Designs and deploys the Quality System for the organization.
- Provides direction to the organization regarding the interpretation and application of regulations. Ensures compliance to regulations is maintained. Informs leadership of the organization’s compliance status, system issues, and identified areas for improvement.
- Oversees the development of processes to monitor deviations to identify trends and areas for improvement. Ensures corrective action and improvement initiatives are effectively deployed and sustained.
- Ensures ongoing data analysis to identify opportunities for performance and process improvement. Uses analyzed data to partner with leadership to drive process change.
- Ensures quality at the source through participation in the selection and/or evaluation of materials, equipment, and computer applications as well as through effective process design.
- Directs the effective design, deployment, and maintenance of methods/software for quality monitoring.
- Provides oversight to the audit program, assesses compliance, and identifies areas for improvement. Ensures audit results are analyzed and trends identified.
- Ensures the submission of documents to regulatory and accrediting agencies. Serves as a liaison with the FDA and other regulatory agencies.
- Reviews and approves final decisions regarding evaluation of nonconforming products, materials, or test results. Ensures customer notification and removal of violative products/test results
- Leads the development and deployment of quality integration strategies for new members.
- Identifies business opportunities and provides services that support Creative Testing’ efforts in retaining and growing the customer base.
- Remains abreast of changes and developments related to industry and establishes and maintains a network of professional relationships.
- Develops and administers the department/center budget.
- Performs all other duties, at the discretion of management, as assigned.
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