Jobs / engineering
Quality Assurance Engineer III
Merit Medical · Maastricht
IND sponsor
What you will do
- Support day-to-day quality oversight of receiving, inspection, storage, picking, packing, shipping, returns, quarantine, and product release activities within the distribution centre.
- Verify that distributed medical devices meet applicable requirements before release, including CE marking, product labelling, instructions for use, UDI, importer information where applicable, and required documentation.
- Ensure storage and transportation conditions remain aligned with manufacturer requirements, including temperature, humidity, segregation, cleanliness, and protection from contamination or damage.
- Manage or support nonconformance investigations, deviations, product holds, quarantine decisions, and disposition activities in collaboration with Operations, Regulatory Affairs, Supply Chain, and Quality leadership.
- Support complaint intake, escalation, investigation coordination, trend review, and communication with manufacturers or responsible economic operators as required.
- Initiate, investigate, and follow up on corrective and preventive actions, including root cause analysis, effectiveness checks, and timely closure.
- Perform process monitoring, quality data analysis, and trend reporting for distribution-related quality indicators.
- Support internal audits, external audits, notified body audits, competent authority inspections, and customer audits by preparing records, responding to findings, and driving remediation actions.
- Maintain and improve local quality procedures, work instructions, forms, training materials, and quality records.
- Participate in change control, risk assessment, validation, equipment qualification, calibration, and process improvement activities impacting distribution quality.
- Promote a quality and compliance culture by providing coaching, training, and technical guidance to warehouse and distribution personnel.
- Performs other related duties and tasks as required.