We’re looking for a candidate to fill this position in an exciting company.
Reports on the performance of the Singapore site quality system including Quality metrics
Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of products, including suppliers and OEM.
Reviews and resolves quality control problems/concerns with Quality Managers, and others including vendors, customers, quality control personnel, and any personnel related to production.
Coordinates and assists with regulatory and notified body, customer and, vendor inspections.
Oversees the process for periodical review of completed quality control checklists, forms, and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards.
Directs internal audit program, and develops corrective action plans and ensures timely resolution of findings.
Receives and reviews customer satisfaction surveys, customer contacts and complaints. Reviews complaint trends and product/component failure analysis; reviews corrective actions with appropriate personnel.
Responsible for post-market surveillance activities as legal manufacturer under IVDR.
Bachelor’s Degree in Engineering or Sciences
6+years of professional experience in quality management systems or in regulatory affairs related to invitro diagnostic medical devices
8+ years of professional quality experience dealing with medical or invitro diagnostic devices; familiarity quality aspects of assay components and chemistries in IVD
Prefer medical device/IVD industry experience, but will consider other industry of quality management experience and skill sets are met.
Able to manage a team in a global matrix organization environment.
Ability to handle uncertainty and mitigate risk.
Able to think strategically, creatively and rationally.
Strong communication (verbal and written) and good interpersonal skills with all levels.
All U.S. colleagues are required to disclose vaccination status. New hires will be asked to disclose vaccination status upon the first day of employment.
All U.S. colleagues working three days or more per week at a site of 50+ colleagues must participate in our free weekly testing program. Those who work on-site less than three days per week are encouraged, but not required, to participate.