Director, Quality

Director, Quality Location: Madison, WI Job Description Summary Establishes and maintains quality assurance programmes, policies, and procedures to ensure that the performance and quality of devices released for commercial and clinical distribution meet applicable regulations, standards and guidelines, including cGMP, 21 CFR 820, ISO 13485, ISO 14971, 93/42/EEC, and IEC 60601. Provides guidance and leadership in the interpretation of governmental regulations, agency guidelines, and internal policies to assure compliance. Serves as Quality Management Representative for the site, acting as the liaison between the company and governmental agencies, hosting inspections, and serving as the point of contact for communications. Job Description Serve as the Madison Site Management Representative with responsibility and authority for ensuring the Madison Quality Management System is effectively maintained in accordance with QSR requirements, and for reporting on Quality Management System performance to the Vice President, Quality for executive review. Supervise senior QA staff and senior consultants; conduct performance evaluations; direct project resources and priorities; resolve quality investigations; and provide direction for the Corrective and Preventive Action programme. Establish and maintain cGMP-compliant Quality Assurance programmes in the device arena by providing input to global policies and procedures, ensuring site QA SOPs and procedures are current, and conducting Management Review meetings in accordance with CFR and ISO requirements. Evaluate and ensure readiness of 510(k) and PMA submissions from a Quality Assurance perspective. Act as Person Responsible for Regulatory Compliance (PRRC) for the INOmax Device Product Line, including ensuring conformity of devices is appropriately checked under the applicable quality management system before release and, for investigational devices, ensuring the applicable statement under Chapter II of Annex XV, Section 4.1 is issued. Participate in transfer teams and product commercialisation activities, working directly with Research and Development organisations and CMOs to ensure products under development meet appropriate guidelines and vendors are qualified according to product stage. Prepare for, host, and follow up on quality inspections and associated activities; ensure site-level Management Review meetings are conducted in accordance with applicable procedures, standards, and regulations. Represent Quality Assurance on project teams in the areas of product planning, project planning, design transfer, change control, and Medical Device Reporting. Sets the goals and objectives and quality objectives for the quality department and site, respectively and performs performance management activities to provide feedback to staff. Support the development of staff through development plans and personnel assessments. Qualifications Education Bachelor’s degree or relevant experience in lieu of degree. Experience Minimum of 10 years of experience in the pharmaceutical, biotech, medical device, or diagnostic industry; at least 5 years in a Quality Assurance role; experience in manufacturing, quality control, quality assurance, or a combination; supervisory experience; experience managing QA employees; hands‑on auditing experience; and vendor management experience. Preferred Skills Knowledge of Class III devices. Ability to work effectively on cross‑functional teams. Basic office software skills, including Microsoft Office. Demonstrated abilities in working with Regulatory Agencies in inspections. Extensive experience with manufacturing process improvement, including budget management, facility enhancement and improvements, lead time reduction, workflow enhancements and capacity management planning. Organizational Relationship/Scope Reports to Vice President, Global Quality. Direct supervision of functional managers and senior consultants. Indirect management of technicians, analysts, specialists, and engineers. Peer relationships with Operations, Regulatory Affairs, Research and Development, Commercial, Quality Services, and similar leadership functions. Scope of position: design, manufacture, and service of medical devices. Working Conditions Working conditions are to be confirmed based on site and role requirements. Benefits Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova Disclaimer The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. At Keenova, we believe that no one should be al #J-18808-Ljbffr