DIRECTOR OF QUALITY ASSURANCE & REGULATORY AFFAIRS, NA

Job Details

Job Location: Nashville - Nashville, TN

POSITION SUMMARY:

The Director of Quality Assurance & Regulatory Affairs (QA/RA) will develop, implement, and maintain a comprehensive Quality Assurance & Regulatory Affairs system in accordance with regulatory/accrediting requirements and in conjunction with the Sunrise Medical Global QA/RA Group. Responsible for ensuring that Sunrise Medical products meet the requirements and expectations for both our customers and our internal stakeholders. Collaborates with cross-functional departments and global functions to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.  Works closely with the Global QA/RA team in post market surveillance activities and global best practices development. The Director of QA/RA will be a highly participative leader, responsible for the hands –on management and direction of Quality Assurance and Regulatory Affairs for North America implementing “best practices”, continuous improvement and corrective/preventive actions as necessary.  The Director is responsible for ensuring that processes and initiatives are compliant with all applicable external standards and regulatory requirements and all applicable Sunrise Medical policies, initiatives, and procedures, as well as successfully interacting with and managing Sunrise Medical’s relationships and compliance with approval agencies such as the US FDA, Heath Canada, etc. Serves as the Person with Regulatory Responsibility (PRRC) and Management Representative for Sunrise Medical North America.

 

The Director is responsible for managing, coordinating, and administering all functions of the Nashville site Quality Department, while serving as a resource to other Nashville functional groups to achieve the objectives of safety, quality, efficiency, productivity, customer service, regulatory compliance, and demonstrating continuous improvement. Responsible for providing direct support and oversight of product and manufacturing engineering activities including manufacturing process capability and supply chain quality management. The Director is responsible for Quality & Regulatory oversight at Ride Designs and Nuprodx, providing guidance and support for QA/RA responsible associates within the Ride Designs and Nuprodx organizations.

Qualifications

PRINCIPAL JOB DUTIES & RESPONSIBILITIES:

• Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs.  Ensures that processes and standards comply with all relevant quality standards and regulations; conducts continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as necessary.
• Manages, coordinates, and administers all functions of the QA/RA function to achieve company compliance and objectives and demonstrate continuous improvement. Provides constructive and relentless guidance in finding solutions for resolving quality concerns and driving improved efficiencies and on-going continuous improvement.  Ensures Quality input into and the monitoring of the Sunrise Product Development Process (PDP) with regard to quality and regulatory compliance.
• Develops and leads a quality and regulatory staff with the skills and abilities to ensure quality products and regulatory compliance for North America.  As required, hires, terminates, evaluates and disciplines employees in accordance with current personnel policies, including performance management and performance improvement plans.  Regularly leads and monitors employees’ performance to assure that departmental goals and objectives are met.  Ensures that staff is adequately trained and responsive to end user needs and complies with all regulatory/accreditation requirements.
• Creates, evaluates and completes domestic and/or international quality and regulatory tasks related to submissions, technical file compilation, and strategy to drive market growth worldwide.
• Collaborate cross-functionally on new product development and strategic initiatives to lead the quality and regulatory activities.
• Oversees Complaints investigation, MDRs, Corrective and Preventive Action (CAPA), HHE/HARM, Supplier Development/Quality and other related processes, including investigations, resolving quality concerns and issues, maintaining all required documentation and track the progress through the system for timeliness and com