Job Summary
We are seeking a highly skilled Quality professional to join our team at LGC Clinical Diagnostics. The successful candidate will be responsible for supporting the Design Control process and ensuring compliance with regulatory requirements.
Duties and Responsibilities
* Design Control Process Support: Assist in the management of Design History Files to ensure compliance with TCD policies/procedures and applicable regulatory requirements.
* Quality Representative: Act as the Quality representative on Design Control projects from project initiation through to product launch, ensuring compliance to applicable procedures and standards.
* Change Control Management: Manage and lead the change control process by liaising with impacted areas to ensure timely and compliant implementation and completion.
* Collaboration: Work closely with R&D, Labelling, Operations, Validation, Business Development, and Supply Chain on design control and change control projects.
* Documentation Review: Review and approve all process validation documentation, including plans, protocols, and reports, to ensure compliance with applicable procedures and standards.
* Risk Management: Responsible for creating and maintaining Risk Management Files for each product.
* Failure Mode Analysis: Facilitate process and design failure mode and effects analysis meetings.
* Procedure Maintenance: Ensure that Design Control and R&D procedures are up-to-date and comply with regulatory or standard requirements.
* Post-Market Surveillance: Perform Post Market Surveillance activities according to applicable procedures and regulations.
* Customer Liaison: Liaise with external customers on change requests.
* Training and Guidance: Provide training and guidance to staff on the requirements of the design control and change control process in TCD.
* Auditing: Perform internal audits to ensure compliance of TCD's quality management system to the requirements of all applicable requirements.
* Additional Duties: Perform other related duties as prescribed by the Global Design QA and Risk Manager and Director of Quality Assurance.
Qualifications and Requirements
* Education: Minimum degree level in Science/Engineering/QA or related discipline.
* Experience: A minimum of 2 years' practical experience required in a quality function.
* Knowledge: Desirable knowledge of risk management, ideally in the IVD or Medical Device industry.
* Regulatory Knowledge: Thorough knowledge of applicable regulatory requirements.
* International Regulatory Knowledge: Knowledge of international regulatory requirements relevant to the business.
About Us
We offer a collaborative and supportive environment where your ideas matter. You'll have opportunities to work on impactful projects in the healthcare sector and contribute to a better future. We also provide a chance to grow professionally while making a tangible difference in people's lives.