Quality Assurance Project Manager
We are seeking a skilled Business Project Manager (QA - Regulatory) to lead initiatives focused on enhancing Quality Management Systems (QMS) and driving digital transformation within regulated manufacturing environments.
Key Responsibilities:
* Maintain and continuously improve the Quality Management System (QMS) in alignment with ISO standards, FDA regulations, and other global standards.
* Ensure compliance with applicable regulatory requirements (FDA, EU MDR, ISO, 21 CFR Part 11).
* Support preparation for and participation in internal and external audits (FDA, Notified Bodies).
* Oversee documentation and management of CAPAs, SCARs, deviations, and non-conformances.
* Integrate quality controls into automated, data-driven manufacturing and digital workflows.
* Collaborate with IT, Manufacturing, and QA teams to embed quality assurance into MES and ERP systems.
* Monitor and validate data integrity across digital platforms used in production and quality control.
* Lead or support IQ/OQ/PQ validation activities for new digital equipment and software systems.
* Review and approve validation protocols, change controls, and technical documentation.
* Ensure audit readiness and compliance of digital systems and electronic records.
* Conduct periodic trending analysis of quality metrics and digital system performance.
* Support predictive analytics and AI-based quality monitoring initiatives.
* Provide guidance on data governance, cybersecurity, and digital traceability.
Preferred Experience & Skills:
* Proven experience in Quality Assurance or Project Management within regulated industries (medical device, life sciences, pharma, or manufacturing).
* Strong understanding of ISO, FDA QSR, EU MDR, and 21 CFR Part 11 compliance.
* Experience managing routers/Bill of Materials (BOMs) and digital manufacturing transitions.
* Hands-on experience with electronic DHR/DHR management and presenting during audits.
* Knowledge of software validation, electronic records compliance, and digital QMS systems.
* Experience leading cross-functional digital transformation projects in a regulated setting.
* Excellent communication, stakeholder management, and documentation skills.
Become part of a team that is dedicated to excellence in quality management and drive your career forward!