Thiaga Wyndow Email & Phone Number

Cirencester, Gb

Warwick, England, United Kingdom

Alcester, England, United Kingdom

Senior Quality Engineer within the Quality Systems department. Responsible for managing the internal audit programme. Conducting internal audits to ISO13485;2016 and participating in external audits.Management of the QMS. Identify and implement process improvements.Monitor and progress Quality issues; complaints, non-conformances, deviations, CAPAs, training, etc.Key projects:Introduction of new eQMS system - implemented January, 2022. Quality lead for the implementation of new ERP system (Dynamics 360) - implemented November, 2022Backroom lead and front room SME for notified body audit - May, 2022

Led quality activities across several product transfer projects;- Developed and introduced the quality strategy for manufacturing transfer of products to the facility at Cirencester - Development of production documentation and quality standards, risk analysis, process walkthroughs, product and process training, FAIRs, measurement system analysis (MSA), creation of process validation protocols and reports- Project leader for transfer of cleanroom from Australia to Corin UK facility at Cirencester- Responsible for resolving product transfer related quality issues

New product introduction, including AQPQ techniques (DFM, FMEAs, control plans, MSA, process validation, process capability, SPC)Internal audits, CAPA and complaint investigations, QMS reviews/updates/training, data and trend analysis for reporting, and worked within FDA response core team to ensure timely and thorough response to observations raised during FDA auditIntroduction of macro-based quality systems to company – NCR (non-conformance reporting), GRN (Goods Return Notice), RGA (return goods authorisation) and QSR (Quality support request) systems and associated software validation

Cirencester

Led and been part of CAPA and complaint investigations (including leading a product recall), internal audits to ISO13485 & FDA 21 CFR part 820, QMS reviews/updates/training, data and trend analysis for reporting

London, United Kingdom

Conducting experiments to compare the encrustation (crystal deposition) rate of urinary stents

London, United Kingdom

- Mentored and motivated first year students on academic and non-academic related issues, in both one-to-one and group settings. - Successfully introduced PASS to the department of engineering in 2008 and worked closely with the PASS organiser to promote and develop the scheme within the department.

London, United Kingdom

Conducted campus tours for potential students and parents and engaed students during open days and taster courses

Queen Mary, University Of London

Contributed to company’s research on hip joint loading patterns by analysing trabecular bone patterns on pelvic CT scans using the software MIMICS. Measured key femoral, acetabular and pelvic parameters on CT scans and performed statistical analysis on the results. Developed an experiment to measure the pressure at the implant-bone surface of an acetabular component during and after impaction.

Denham

Frequently chosen for roles involving direct customer interaction during busy hours due to my ability to provide a quality service under pressure.

Master Of Engineering (Meng), Medical Engineering, First Class Honours

A-Levels, Physics (A), Maths (B), Chemistry (B)

GCSEs: Grade A in 10 subjects including maths and science