A leading medical device company at the forefront of biosensor technology we are dedicated to pioneering innovative, rapid near-patient, point-of-care in-vitro diagnostic solutions on our proprietary nanowire biosensor platform. we uphold the highest standards of quality, ethical behavior, and integrity in everything we do.
Are you ready to make a significant impact in the field of medical devices? We are seeking a Site Quality Leader for our pilot manufacturing facility. In this pivotal role, you will be instrumental in ensuring the quality and regulatory compliance of our cutting-edge medical devices. Your leadership will drive the management and continuous improvement of our quality management system (QMS), enabling our IVD products to secure FDA and international regulatory approvals. By fostering a culture of quality across cross-functional teams, you will play a vital role in helping the Company achieve its strategic and business objectives.
Your duties will include:
- Resolving product quality issues, including overseeing compliant and effective temporary planned deviations, non-conformance reports (NCRs), and corrective preventive actions (CAPAs).
- Managing equipment, test method, and process validation programs.
- Overseeing warehouse operations, including receiving, distribution, inventory management, identification, and traceability.
- Managing product labels/labeling, including workflows for new and revised label-related changes.
- Ensuring the quality of new and design-transferred products, along with associated product specifications and configurations developed by Design Engineering.
- Establishing and maintaining robust communication channels between engineering, manufacturing, operations, and other stakeholder functions to address critical quality issues that may impact product integrity and business continuity.
- Regulatory Compliance: prepare and manage submissions to regulatory authorities, and when necessary, participate in interactions with FDA and EMA.