Location - Dundee, Scotland
This is an opportunity to work with a leading expert in the diagnostics sector who have a fantastic opportunity for a QC Scientist.
As a QC Scientist you will perform incoming, in-process and final testing on the product range, ensuring that all QC Activities comply with ISO 9001 and ISO 13485.
- Carry out incoming, in-process and final tests to support manufacturing and R&D activities using calibrated equipment and in accordance with QC Procedures (DQCPs).
- Carry out cross-over studies where required and carry out stability testing at scheduled intervals.
- Record results and generate reports/maintain spreadsheets.
- Manage QC inventory.
- Carry out release of product using the Sage ERP system.
- Initiate required changes to QC documents in accordance with change control procedures; similarly, in conjunction with R&D, for new procedures to support product development.
- Record and investigate out of specification and out of trend results; also, deviations. Alert Compliance Manager to any significant quality problem that is identified.
- Ensure that all interactions with internal and external customers are professional.
- Lead or participate in quality improvement opportunities within QC.
- Ensure all activities comply with Health and Safety legislation or BBI policies.
- Ensure that all QC activities comply with ISO 9001, ISO 13485 and the FDA Quality System Regulation, CFR Title 21 Part 820.
- Science Based degree.
- You will be required to have practical experience within the Medical Device Sector OR Pharmaceutical industry with FDA GMP requirements.
- Laboratory experience, report writing experience and be proficient is MS word and Excel.
- You will be organised and methodical with the ability to prioritise, manage time well, multitask and troubleshoot.
- Competitive Rates and the opportunity to work with exceptional products and technologies that people rely on to enjoy a better quality of life.
For more information, please call Suzi on or e-mail a CV to