Our Client, an Innovative Medical Device Contract Manufacturer based in Suffolk have an exciting opportunity for an experienced Quality Validation Engineer to join the Team. You will be a pivotal member of the group in all aspects of quality across the company. To perform and document quality investigations, resolve production quality issues and being the site lead for process validation activities. Supporting the quality inspectors in their absence, performing in-coming, in-process, first article and final inspection and testing duties to ensure that shipped products fulfil all customer specifications and quality requirements. Managing all QA aspects related to design, process and sterility validation.
- To maintain QMS to meet standards across the company such as ISO 13485, MDR, UKCA and cGMP/FDA
- To perform quality and engineering investigations and validations using tools and techniques relevant to the medical device industry and modern manufacturing such as risk management, IQ, OQ, PQ process validation, continuous improvement and lean six sigma techniques.
- Improving quality throughout the company whilst minimizing the effect on profitability.
- Where necessary, perform accurate mechanical, physical and visual inspection of in-coming raw materials, in-process and finished products as per inspection plans and specification requirements.
- Maintain activities required to support the Quality Management System
- Writing and review of cGMP documentation, implementing new documents where necessary.
- Be knowledgeable of and understand quality standards and models preferably gained in a medical device industry
- Process Validation and Quality Assurance background
- Be strategic, methodical, logical and detail orientated.
- Be able to investigate, document and maintain records accurately.
- Be extremely professional, customer friendly and amenable.
- Be an excellent communicator.
- Able to read and interpret specifications and part prints.
- Ability to work independently with minimal guidance.
- Good time management, planning/organisation, and decision-making skills.
- Ability to meet rigorous deadlines for reports and studies.
- Be multitalented and able to perform different roles.
- High level mathematical skills including statistical techniques
- Have a in depth understanding of ISO 13485, cGMP/FDA/MDR standards and other medical device related directives and standards
- ISO 9001 or ISO13485 Lead Auditor (preferable) or Internal Auditor
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.