Description
- Analyze, evaluate, and present information concerning business and quality issues relative to the design, development and manufacture or distribution of products, for consideration by other members of the management team.
- Along with the Director of Regulatory, serve as a representative in all dealings with regulatory agencies (FDA, Notified Body, etc.) relative to medical device design, manufacture, re-packing and distribution.
- Review technical reports and summary documents for quality and adherence to regulatory guidelines, strategies and commitments.
- Timely investigation and effective closure of Customer Complaints.
- Manage the CAPA process and monitor commit dates to drive timely closure of actions.
- Manage the quality audit system including auditor training for internal audits.
- Review the documented Quality System for continued adherence to, 510k submissions, technical files, or any other stated agreement between the Corporation and the appropriate regulatory agency.
- Lead the Management Review meetings.
- Suggest and debate alternative methods and procedures in solving problems and meeting changing market opportunities.
- Cooperate with other top management personnel in formulating and establishing company policies, operating procedures, and goals.
- Conduct meetings with Quality Assurance management staff to establish, delineate, and review organizational policies, to establish responsibilities and procedures for attaining objectives.
- Review technical problems and procedures of Quality Assurance and recommend solutions to problems or changes in procedures.
- Review technical publications, articles, and abstracts to stay abreast of technical and regulatory developments in industry.
- Plan, promote, and organize training activities related to Quality Systems requirements.
- Initiate further actions regarding the disposition of any distributed product that does not meet regulatory requirements of quality, efficiency, or safety up to and including product recall.
- Organize and direct subordinates to meet departmental and corporate needs.
- Ensure that all personnel are properly trained.
- Evaluate performance and approve compensation changes on all subordinates.
- Ensure that SOP's are maintained in accordance with the Quality System.
- Membership and participation in all meetings of the Noblesville Leadership Team.
- Ensure compliance with all SOP's.
- Ensure that all work is performed in compliance with the QSR's and, MDD, ISO 13485 requirements.