Thomas Mole Email & Phone Number

Birmingham, GB

Birmingham, England, United Kingdom

• Providing technical support for the full range of Protein Diagnostic products including Freelite, Hevylite and General Nephelometry but specifically focused on the EXENT Mass Spectrometry instrumentation and assay.
• At all times, ensure that statutory requirements from various regulatory bodies, company policies and procedures are adhered to, including but not limited to ISO9001:2015, ISO13485, IVDD 98/79/EEC and US/FDA.
• Making informed decisions on the quarantine and correction of Protein Diagnostic products.
• Manage customer/distributor/subsidiary expectations, providing recommendations on how to improve the effectiveness, efficiency, and delivery of services through the use of technology and technical reporting methods.
• Conduct and take part in Post-Market Surveillance and Vigilance activities including field safety corrective actions, serious incident data and monitoring feedback and complaints from users.
• Lead Quality Review Group Meetings and undertake risk and impact assessments following confirmed non-conformance's.

Birmingham, England, United Kingdom

• Perform the qualification, validation and troubleshooting of test methods and assays (ISO 13485:2016).
• To carry out technical design changes to existing products or processes when required and assist in the investigation of escalated technical complaints.
• Communicate and work in tandem with a variety of departments from Quality Assurance and Regulatory Affairs to Production and R&D.
• Project Management and the implementation of improvement projects within a manufacturing environment and ensure that such projects are completed in an efficient manner.
• Making informed decisions on the progression or possible scrapping of Protein Diagnostic products, having reviewed all of the necessary information, and communicated with all appropriate areas within the organization.

Birmingham, England, United Kingdom

• Writing QC documents such as Standard Operating Procedures and Product specifications.
• Designing new processes and process spreadsheets.
• Writing technical and process Non-Conformance Reports.
• Using statistical software such as Minitab to perform and conduct statistical analysis on large datasets.
• Designing and performing experimental and investigational procedures.
• Performing Root Cause Analysis using the application of technical knowledge to successfully troubleshoot a wide variety of immunodiagnostic assays in an efficient and timely manner.

Birmingham, England, United Kingdom

• Experienced in following COSHH forms and GLP procedures.
• Performing instrumentation training of several Turbidimetric and Nephelometric analysers including Optilite and Siemens BNII platforms.
• Data Checking large quantities of data.
• Carrying out several types of immunodiagnostic assay testing whilst following procedures to regulation and quality guidelines.