Project Manager, Quality Compliance
Position Overview
Responsible for managing projects for global quality compliance program. Work closely with various functions to drive investigation of issues, effectively implement solutions, and enhance quality compliance activity. Ensure the accuracy of all quality system related information to support regulatory submission or registration renewal, audits, and inspections. Stay informed of all applicable quality system standards/regulations and drive compliance to meet the new and updated standards/regulations. Revise and update the training materials to ensure they reflect the latest quality compliance standards. Disseminate and deliver the current quality compliance information to the affected associates in a timely and appropriate manner. Job duties:
- Manage the global quality audit related activities, including preparing audit schedules; communicating with audited functions; coordinating discretional audits; coordinating and leading audit execution (e.g., products, processes, and quality systems); preparing audit reports; ensuring information is properly documented in the appropriate audit system; and reviewing documents to address audit findings.
- Manage third-party related audits and/or regulatory inspections.
- Develop, update, and perform quality compliance training.
- Develop and maintain centralized quality compliance related information to support audits, inspections, regulatory product registration, and requests from other functions.
- Establish, organize, consolidate, and maintain files, records, and verbal and written communication with the regulatory agencies. Stay informed of all applicable quality system regulations/standards and perform gap assessments to new or revised quality systems regulations/standards.
- Serve as a project manager for driving projects/ initiatives and working with cross-functional teams to ensure timely compliance with newly implemented or updated quality systems regulations/standards.
- Support and contribute to developing, editing, or revising quality system processes.
- Collaborate with cross functional team and mentoring team members as required.
- Provide updates to management on the status of the Quality Compliance program.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- BA/BS degree or equivalent combination of education and experience.
- Minimum five (5) years of quality compliance related experience in the medical industry including combination products.
- Valid quality auditor certification by a recognized organization (e.g., ASQ CQA, ASQ CMDA, Global Exemplar Medical Device Management Systems Auditor, etc.).
- Knowledgeable in 21CFR820, 21CFR803, 21CFR806, 21CFR Part 4, ISO13485, ISO14971, MDD, CMDR, MDSAP, and Regulation (EU) 2017/745.
- Experience interfacing with relevant regulatory authorities and/or notified bodies.
- Experience in leading project teams.
- Successful experience working independently and in a team environment.
- Proven analytical abilities, organization skills, and attention to detail.
- Strong project management skills and ability to handle multiple projects concurrently.
- Strong technical writing skills and verbal communication skills.
- Proficient computer skills, including MS Project, Word, Excel, PowerPoint, Outlook, and Teams.
- Advanced degree in a scientific or technical discipline or relevant field of study.
- Project Management Professional certification.
- Ability to understand the technology related to MicroVention’s products.
- Minimum two (2) years of experience managing quality audit program/department.