Quality and Compliance Officer – Medical Devices
This is an exciting opportunity for an experienced quality professional to support the design, development and manufacturing of innovative medical devices for first-in-patient clinical investigations.
The post holder will be based in the School of Biomedical Engineering & Imaging Sciences, King's College London. Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide. The Quality and Compliance Officer will support the operation of the new facility for the Manufacture of Active Implants and Surgical Instruments (MAISI) and work with research teams developing state-of-the-art medical technology, including surgical robotics, imaging software and AI, to follow the Medical Engineering Quality Management System (QMS) procedures.
The individual will join a growing Quality Team and work with clinicians, staff and students in a clinical academic setting to ensure medical devices meet regulatory, quality and safety standards. You will be required to work on implementing and maintaining key processes in the quality system and will be joining the team as the manufacturing facility is constructed and undergoes validation in 2023.
The individual will report to the Manufacturing Quality Assurance Lead – Medical Devices, and work with all users of the QMS including production staff, research groups, and top management. The post holder will be required to ensure compliance and readiness of the quality system to ISO 13485 in preparation for certification.
This post will be offered on a fixed-term contract for 2 years
This is a full-time post - 100% full time equivalent
• Perform document control activities, including creating, distributing, modifying, storing and reviewing documents and records. Inform staff of the release of new documents and revisions.
• Manage and retain accurate records of any reported deviations and violations.
• Coordinate and manage completion of complaints, change control, non-conformance, corrective and preventive actions.
• Assist with management of training records as required.
• Schedule Management Review and Quality Meetings, ensuring outputs are recorded.
• Reviewing and approving validation plans/protocols and reports.
• Supporting the requestor, when required, in the processes associated with supplier planning for supplier approval. Conduct supplier evaluations.
• Support cleanroom team with review and approval of commissioning, IQ, OQ, PQ, validation and operating documentation.
• Perform QA product release and batch record review of sterile and non-sterile products.
• Assist in inspection, approval and testing of incoming materials and components.
• Review the monitoring and reporting of cleanroom environmental monitoring, product bioburden trends etc.
• Participate in internal and external audits
• Support the operation and implementation of an electronic QMS
• Support manufacturing QC testing program
• Initial review of documents and batch records
• Ensure compliance of quality system and collate quality system metrics
• Organise, deliver and participate in internal and external training sessions
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
1. Degree or equivalent experience in engineering discipline (biomedical, electronic, mechanical, materials), quality, or related subject.
2. Knowledge of quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.
3. Experience in writing and reviewing quality system documentation including standard operating procedures, templates, forms and records, to ensure compliance with requirements.
4. Knowledge / experience of good manufacturing practices and medical device or similar cleanroom manufacturing and operation.
5. Experience of developing and implementing appropriate measures and tests of quality.
6. Competence in use of QMS and IT tools, including MS Office, Sharepoint, MS Teams, Word, Excel and Outlook.
7. Experience in document control and use of document management system.
8. Attention to detail with excellent organisational, written, verbal communication skills and ability to troubleshoot.
9. Ability to work collaboratively with different teams to agreed deadlines.
10. To embrace the challenge of setting-up a new facility be flexible, open-minded and creative with innovative ideas and a can-do attitude to provide solutions to establish a compliant facility.
1. Experience of monitoring and reporting of cleanroom environment, product bioburden trends, or endotoxin testing.
2. Participation in audits.
3. Experience of chairing meetings and taking formal minutes.
4. Experience of QC testing