Based in Stirling, Scotland but will travel UK wide (hybrid)
£55-65 p/hour
Outside IR35
Available from 3rd April 2023

A Lean Six Sigma Black Belt, PRINCE2 and Agile (Project Management) Practitioner and Scrum Master with more than 15 years post-graduate experience in the GMP pharmaceutical/medical device industry.  

Experience in both QC, as an Analytical Chemist working on the analysis of raw materials, manufacturing intermediates, finished samples and stability samples in R&D developing analytical method and Validating (URS/IQ/OQ/PQ) equipment. After this, as a Senior Scientist with a greater scope and range of work, he became a Lean Six Sigma Black Belt. After this he became a PRINCE2 Practitioner Project Manager, followed by Agile Project Management and Scrum.

More recently worked as a contract Design Engineer on a Remediation Project going through Design History Files of Medical Device Products for the implementation of MDR/IVDR audit by regulatory authorities to ISO 13485 and ISO 14971. Also qualified as an ISO13485 Internal Auditor.

Skills Used:

• ISO 13485 and ISO 14971
• MDD 93/42/EEC and MDR 2017/745
• Minitab, Design of Experiments, and ad hoc Statistical Support for projects (data analysis and interpretation).
• Microsoft Office Suite including Project and Visio.
• Leading Process Mapping Exercises.
• SOP and documentation update.
• FMEA
• Writing Design Implementation Instructions I.e.