Manager - Quality

Essential Functions:

• Oversees the design and implementation of company audit procedures. Establishes systems and standards for conducting audits.
• Manages the internal audit lifecycle including but not limited to planning, execution, reporting, managing response, and following up on commitments/capabilities.
• Performs audits to evaluate current processes against established procedures as documented in standard operating procedures (SOPs) and work instructions.
• Develops, implements, and manages a “secret shopper program” to audit outgoing product quality.
• Reports audit findings to appropriate division/departments in a timely fashion.
• Formulates and maintains quality control objectives, and coordinates objectives with production procedures in cooperation with other managers to maximize quality and reliability and to minimize costs.
• Supports the design and implementation of a robust and compliant framework of current Good Manufacturing Practice (cGMP) procedures.
• Plans, promotes, and organizes training activities related to quality and reliability.
• Analyzes existing procedures and processes to identify existing best practices.  Assures integration of internal and external industry best practices into the future state QMS.
• Oversees the Technical Writing team and ensures that the Quality procedures, operating procedures, and work instructions are maintained or updated within the established review period.
• Collaborates with Learning & Development to assure that appropriate individuals are trained on QMS changes and updates in accordance with Company policies.
• Establishes and integrates metrics necessary to assure sustainability of quality system elements.
• Oversees internal and external audits on the quality system to check for conformance to policy and regulations.
• Builds and fosters strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
• Serves as key quality systems subject matter expert and works closely with Learning & Development to drive organizational competency in quality system requirements.
• Hires, manages, develops, reviews, and sets goals for department and staff.
• Conducts performance evaluations, recognizes, and acknowledges positive and productive behavior, and provides constructive/corrective feedback for performance issues.
• Manages staff in accordance with Company policies and procedures. Enforces adherence to Company policies and procedures.
• Coordinates with Human Resources and management in a timely manner on all employee relations matters.
• Ensures all direct reports understand the performance standards of their department and have a clear understanding of their own individual performance.
• Serves as both coach and mentor to staff in areas of problem solving, decision-making, process improvement, and personal growth.                                                    
• Promotes career training and development of direct staff to support the ongoing acquisition and refinement of skills and knowledge, including job mastery and professional development.
• Performs other duties and projects as business needs require at the direction of management.

Education and Experience:

• Bachelor’s degree in Engineering, Science, or related field required.
• Minimum seven (7) years of experience in developing, designing, and managing quality systems required.
• Minimum five (5) years in a leadership/management role required.
• Previous experience in the dental industry or medical device industry a plus.

Special Requirements/Certification:

• Certified Manager of Quality/Organizational Excellence (CMQ/OE/ASQ) a plus.

 
Pay Range: $100k-$130k