Position: Manufacturing Inspector
Location: On-site, Oxford, UK
Global, innovative medical device company dedicated to improving patient outcomes and saving lives. Our company specializes in advancing technology in Medical Devices and is committed to making a global impact.
They are expanding operations and seeking a motivated Manufacturing Inspector to join our team.
Position Overview
The Manufacturing Inspector will play a key role in supporting daily manufacturing activities and conducting product release testing for medical devices. The role involves performing and documenting in-process inspections and a variety of technical tests on assemblies, sub-assemblies, and finished products.
This position offers the opportunity to contribute to impactful work in a fast-paced environment. It is a flexible, on-site role based at our facility in Oxford, UK.
Key Responsibilities
* Ensuring adherence to Good Document Practice (GDP) and Good Manufacturing Practice (GMP) standards by inspecting subassemblies and final products against established release criteria.
* Carrying out and recording inspections during production, along with performing technical evaluations on assemblies, sub-assemblies, and completed devices.
* Contributing to initiatives aimed at achieving measurable improvements in performance.
* Assisting with the resolution of non-conformance issues, investigations, and exceptions related to manufacturing processes or products.
* Conducting routine inspections of manufacturing areas, including General Area Line Assessments (GALA) checks.
* Identifying and analyzing trends from GALA assessments, non-conformance reports, and final batch release reviews.
* Reviewing and maintaining the accuracy and relevance of work instructions, SOPs, and test specifications, and implementing updates when needed.
* Serving as a Subject Matter Expert (SME) in assigned areas, supporting regulatory audits such as those conducted by BSI or FDA.
* Taking on additional duties as reasonably requested by the Manager of Outbound Quality.
Skills and Experience
* A thorough knowledge of GDP and GMP requirements.
* Proven experience in drafting and updating standard operating procedures, work instructions, and specifications.
* The ability to interpret technical drawings and apply inspection criteria effectively.
* Hands-on experience in manufacturing processes within the medical device industry or Pharma industry
* Proficiency in using basic measurement tools such as calipers, jigs, and gauges.