Working within our 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.
Cambridge Design Partnership is a successful innovation partner focused on creating value for our clients by transforming new ideas; stakeholder centred design and applied technology into commercial success.
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!
- 2.1 or 1st in 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 you have the skills and personal qualities to succeed in this role, please send your CV with current remuneration details to firstname.lastname@example.org