Works in conjunction with team members to develop, implement, and maintain the corporate quality system.
Ensures that the quality system is established, implemented, and maintained in accordance with the requirements established by FDA and other regulatory agencies. Includes ensuring conformance to industry and international standards as applicable and appropriate.
Participates in the internal audit program to assure ongoing compliance. Conducts audits as lead and/or supporting auditor per the audit schedule.
Directs the complaint handling program to ensure complaints are identified, processed, and investigated per internal procedures and regulatory requirements.
Oversees all activities related to the corrective and preventative action (CAPA) process. Tracks CAPA investigations through completion, implementation, and verification to ensure identified nonconformances are corrected and recurrence prevented.
Assists with supplier qualification, including participation in desk and/or on-site audits of suppliers as required.
Participates in FDA and other regulatory inspections.
Generates and presents reports for Management Reviews at prescribed intervals.
Performs all duties and responsibilities as required by Merge’s Quality System Policies and Procedures.
BA/BS in a scientific discipline or related equivalent experience including a minimum of 3 years in the medical industry including quality system audit experience. Understands and implements the quality system in accordance with FDA QSRs, ISO 13485, MDD, and CMDR.
Must be well versed in the medical device quality system regulations with experience in a quality and/or regulatory department within the medical industry.
Specific experience with software medical devices desired.
Excellent communication and interpersonal skills are essential.
Willingness to handle day-to-day quality system issues by taking an active role in defining issues and proposing solutions.