Establishes and maintains quality assurance programs, policies, and procedures to ensure that performance and quality of devices released for commercial and clinical distribution meet applicable regulations, standards and guidelines (cGMP, 21 CFR 820, MDSAP and ISO 13485, ISO 14971. 93/42/EEC, IEC 60601, etc). Provides guidance and leadership in interpretation of governmental regulations, agency guidelines, and internal policies in cGMPs to assure compliance. Serves as Quality Management Representative for the site, which is the liaison between the company and the various governmental agencies to host inspections and act as point of contact for communication.
Director of Quality is the Madison Site Management Representative with responsibility and authority for ensuring the Madison Quality Management System are effectively maintained in accordance with the QSR, ISO 13485:2016 and MDSAP requirements and reporting on the performance of the Madison Quality Management System to the Vice President, Quality for executive review.
Supervises senior QA staff and senior consultants. Conducts performance evaluation of QA staff, directs project resources and priorities, resolves quality investigations, and provides direction on the Corrective and Preventive Action program.
Establishes and maintains cGMP compliant Quality Assurance programs in Device arena by providing input to Global Policies and Procedures, ensuring Site QA SOPs and procedures are kept current; conducts Management Review Meetings as per CFR and ISO requirements
Evaluates and ensures the readiness of 510(k) and PMA Submissions from a QA perspective.
Participates on transfer team and product commercialization. Works directly with Research and Development organizations, Global Device Engineering as well as CMOs to ensure that products under development meet appropriate guidelines and ensure that vendors are qualified appropriately based on the stage of product.
Prepares for, hosts, and follows-up on quality inspections and associated activities. Ensures Site level Management Review meetings are conducted per applicable procedures and in accordance with applicable standards and regulations
Represents QA on project teams in the areas of Product Planning, Project Planning, Design Transfer, Change Control, and Medical Device Reporting.
Collaborate and engage in Global Operations Quality projects, programs and activities.
MINIMUM REQUIREMENTS :
Bachelors Degree, Masters preferred
Minimum of 10 years of experience in the pharmaceutical/biotech/medical device/diagnostic industry; at least 5 years in a Quality Assurance role; experience in manufacturing, quality control or quality assurance or a combination; supervisory experience; managing QA employees; hands-on auditing experience; vendor management.
Knowledge of Class III devices; ability to work on cross-functional teams.
Office software skills (eg. Microsoft Office).
Travel Periodically 10% - 15%
RELATIONSHIP WITH OTHERS:
Direct supervision of functional managers and senior consulting.
Indirect management of technicians, analysis, specialists, engineers.
Peer to Operations, Regulatory Affairs, Research and Development, Commercial, Quality services and similar leadership functions.
SCOPE OF POSITION:
Design, Manufacture and Service of Medical Devices