We are seeking a Chief Technical Assurance Officer to support all aspects of technical assurance for our Urology Scopes portfolio. This role offers a significant opportunity to gain in-depth knowledge of the Quality System, particularly Production and Process Controls.
Key Responsibilities:
* Process & Quality Control: Develop an in-depth understanding of the manufacturing process for Urology Scopes products, including all aspects of production and process controls.
* Compliance & Audits: Lead back-room activities and provide front-room support during external audits, ensuring the production unit remains audit-ready at all times.
* Continuous Improvement: Identify and control manufacturing-related process defects by leading root cause investigations and implementing corrective and preventive actions.
Leadership & Communication: Coordinate and conduct technical investigations of non-conforming events using eCAPA and Engineering Essentials.
Knowledge & Skills:
* Strong working knowledge of Quality Systems, particularly Production and Process Controls, Process Acceptance Activities, Non-conforming product controls, and CAPA.
* Proficient in problem-solving and process improvement methodologies.
Qualification Requirements:
* Level 8 honours degree in Engineering, Quality, or Science.
* Minimum 5 years' experience in a medical device or related regulated industry.