QUALITY SYSTEMS MANAGER

Position Summary:

This position is responsible for carrying out established directives, procedures, systems, and processes. Additionally, the Quality Systems Manager (QSM) is responsible for direct support supervision. This position will serve a primary role in Quality compliance activities including ISO 9001, AS9100, ISO 13485/MDSAP, or any other required regulatory compliance activity. The QSM will also serve as a primary quality management system (QMS) documentation resource for both Curbell companies and act as the Lead Internal Auditor for schedule creation, tracking, training, and management for Curbell's internal auditors. Regulations and quality standards are subject to change and this position will stay current with those regulations and quality standards that affect Curbell's QMS. The QSM will support design engineering efforts as required, author technical reports, support complaints and corrective actions, perform risk analysis and design reviews, supports external audits, and submit various device license applications and/or medical device reports as necessary.

Essential Functions:

• Compliance - Serves as the Lead internal auditor for both Curbell companies.  Develops, identifies, and maintains systems for company-wide compliance with all applicable regulations, both voluntary and compulsory.  Coordinates and schedules internal audits and support external audits.  Ensures all internal auditing members are trained and competent to the applicable standards.  Maintains the overall responsibility for both company’s QMS compliance. Works with various departments in both Curbell companies to ensure that relevant quality regulatory standards are implemented and compliant. Provides input and direction to various corrective action activities and supports both customer and supplier matters as appropriate.

• Documentation - Responsible for producing accurate, accessible, consistent records and reports. Develops and publishes reports. Maintains the QMS so that it stays current with all applicable voluntary and compulsory regulations. Works with Legal to develop standardized processes to ensure uniform responses to customer inquiries. Develops systems as needed to provide tracking and records of compliance activities.

• Leadership - Develop a culture of high performance and employee engagement by inspiring, developing, and motivating internal talent. Facilitate good discussions with employees in order to understand their professional goals and aspirations. Create an environment of open communication that fosters upward feedback and suggestions. Make well informed decisions, demonstrate initiative, exhibit autonomy and execute on organization initiatives. (Measure by Employee Engagement and Retention).

• Problem Solving - Coordinates and manages the resolution of problems using advanced methodologies as defined by internal and external customers.

• Performs other duties as assigned.