Quality Engineer. Core Purpose: In this role you will provide leadership, knowledge and expertise in the area of quality and assurance for the site, whilst also supporting other activities in relation to Quality Engineering and Quality Systems. Core Responsibilities: Management of the non-conformance process, including containment, root cause analysis and product disposition. Plan, document and implement process validations in accordance with best industry standards and corporate templates. Support Process Engineers in validation and change management activities. Act as plant representative during Design Transfer and Design Review meetings with QA & R&D. Compilation and reporting of quality metrics to Unit Quality. Responsible for managing the disposition of non-conforming components with material suppliers. Drive Quality Improvement Plans at the plant, to reduce QN's and customer complaint occurrence. Responsible for CAPA ownership and timely and thorough execution of CAPA’s. Ensure compliance of the Quality System with all applicable medical device regulations as well as the Corporate Quality System. Act as a member of the Internal Audit team, conducting internal audits per the annual schedule. Support the investigation of customer complaints as required. Support the batch release process and release function. Preparation of Quality reports for quality meetings and management reviews. Active participation in all local and world-wide quality meetings. Contribute to plant maintaining ongoing compliance with ISO13485 and 21CFR820. Act as Subject Matter Expert for Notified Body/Regulatory Audits. Support Quality Engineering/Continuous Improvement activities as required. Ensure adherence to all regulatory requirements. Liaising with both internal and external customers on quality issues. Promotion of Quality Awareness and cGMP within the plant. Training of associates on Quality procedures and initiatives. SOP writing and maintenance. Qualifications & Experience. Educated to degree level in Engineering, Science or a Quality related discipline. Experience in a regulated medical device or pharmaceutical environment, with exposure to ISO 13485. Experience in moulding and process validation along with CAPA and non-conformance, problem solving and preventative measures skills Ideally. Strong and influential communicator with attention to detail and process excellence.
216 days ago