Quality Systems Specialist

This position is responsible for carrying out established directives, procedures, systems, and processes.  Additionally, the Quality Systems Specialist (QSS) is responsible for direct support supervision. This position will serve a primary role in Quality compliance activities including ISO 9001, ISO 13485/MDSAP, or any other required regulatory compliance activity.  The QSS will also serve as a primary product compliance resource for both Curbell companies, will serve as the central point of contact for coordination and procedural creation, and act as the Lead Internal Auditor for schedule creation and tracking, training, and management and direction 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.  The QSS will support design engineering efforts as required, author technical reports, perform risk analysis and design reviews, and submit various device license applications and/or medical device reports as necessary. 

• Compliance - Develops, identifies, and maintains systems for company-wide compliance with all applicable regulations, both voluntary and compulsory. Coordinates and schedules internal audits and supports external audits. Maintains the overall responsibility for both company’s QMS compliance.  Works with Procurement Department(s) on the collection, organization and distribution of product related data and leads the communication and training of business partners up and down the supply chain.  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.

• Detail Orientation
• Multi-Tasking
• Problem Solving and Decision-Making
• Relationships, Influence & Problem Resolution
• Catalyst for Action & Change
• Coaching/Developing People And Teams