Quality Engineer / Design History Files / Audit / Internal / External / QMS / 13485 / Compliance / V

X4 Group
£30k - 45k per year
27 Sep 2016
20 Oct 2016
Contract Type
Location : Cambridge Salary : £30,000 - £45,000 (Depending on experience) Job Title – Quality Engineer I’m currently working with a company based in Cambridge who are looking for a Quality Engineer to join their team. The ideal candidate will have a good understanding of ISO 13485 as well as Design History Files. JOB DESCRIPTION REQUIREMENTS Working within the multidisciplinary teams on major product development projects, you will be responsible for the development, evaluation and auditing of Design History Files (DHF) internally as well as for our suppliers and clients for a range of products and processes in primarily the medical sector. Your challenge is to document gaps affecting design control elements such as inputs, outputs, design verification and validation, DMR, etc and remediate as necessary in a tactful, professional and effective manner. You will be making a real difference whilst receiving an excellent benefits package. Our benefits include a competitive salary, discretionary performance-related bonus, 12% non-contributory pension scheme, private healthcare and 25 days holiday plus statutory holidays. With our offices in a beautiful rural location close to Cambridge, we offer an exciting and challenging working environment where development timescales are short and the specifications demanding but rewarding. An excellent opportunity to join a technical consultancy that’s exciting and going places 2.2 or above in Engineering or other Physical Sciences Quality Management experience in the medical device and/or pharmaceutical manufacturing area Experience in FDA 21 CFR Parts 820, 211 and 210 quality system requirements. Experience in ISO 13485 quality management system requirements Experience in ISO 14971 – Application of Risk Management to Medical Devices Risk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEA Good knowledge of Design History File Documents; Plans, Design Inputs, Verification, Validation, Design Reviews, Design Outputs Change Management, Discrepancy Management, Complaint Handling and CAPA Experience of internal/external auditing Ability to write factual reports in a methodical and timely manner Ability to communicate findings to clients at all levels Ability to lead projects, taking responsibility for quality, time and profit Bright, conscientious and creative with an ability to demonstrate a hobby or interest with a practical or technical relevance If this is something you think you would be interested in then send a copy of your most recent CV to and call Jack Lundgren on. Key Skills: Quality Engineer / Design History Files / Audit / Internal / External / QMS / 13485 / Compliance / Validation / Verification This job was originally posted as www.totaljobs.com/job/66724818