Quality Control Manager

X4 are currently collaborating with a world leading healthcare technology and diagnostics company in the search for a highly skilled Quality Control Manager to join their team based in Wiltshire, UK.

This role will involve managing the QC function and team as well as in-depth analysis and refinement of the assay methodologies, including QC test methods development and validation for raw materials, reagents and finished products, currently under development as well as stability testing.

Main responsibilities:

• Design and develop system-based nucleic acid assays.
• Design and perform experiments, prepare technical reports, analyze data sets and present results.
• Post Market Surveillance.
• Evaluation and validation of assay performance against assay requirements.
• Development/preparation of quality system procedures and documentation.
• Transfer laboratory-developed assays to both system prototypes and final cartridge.
• Verification and validation of final product.

Qualifications and Skills:

• BSc in a relevant scientific discipline.
• Significant (>3 years) relevant technical experience.
• Nucleic acid assay development experience.
• Commercial IVD product development experience.
• Quality Management & Regulatory frameworks, ISO 13485, FDA 21 CFR 820 and cGMP.
• Previous line management experience.
• Strong laboratory-based background.
• Attention to detail and well organized.

Please share you CV at e.smailes@x4 (url removed) if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.