Freelance Quality Assurance/Regulatory Affairs Associate
Colchester, United Kingdom
Quality Assurance Manager @ From June 2014 to Present (1 year 7 months) Colchester, United KingdomQuality Assurance Manager @ Conducted regular team meetings and encouraged development to achieve key performance metrics for the site in supplier and product quality. Delivered on the integration of SAP P41 Quality Management modules into the Quality Assurance department. Established an IQA...
Quality Assurance Manager @ From June 2014 to Present (1 year 7 months) Colchester, United KingdomQuality Assurance Manager @ Conducted regular team meetings and encouraged development to achieve key performance metrics for the site in supplier and product quality. Delivered on the integration of SAP P41 Quality Management modules into the Quality Assurance department. Established an IQA Department by recruiting and training Inspectors. Actively participated in the Global Supplier QA Team to collate best practices on supplier selection, addition and evaluation of suppliers.Introduced new procedures and system non compliances. Coordinated site supplier audits in line with Siemens Diagnostics Global audit plan. Actively participated in New Product Introductions as Quality lead. From May 2007 to July 2014 (7 years 3 months) Product Quality Manager @ New Product Introductions projects, rewriting Technical files and production of Quality Plans. Resolved Quality issues as they occurred on the shop floor, liaising with Manufacturing, Procurement and Suppliers. Audited internal operations to GMP & ISO 9001 and ISO 13485 as required for relevant UK, European and US component suppliers. Analysing root cause and implementing corrective actions on CAPA for supplier, process and component quality problems Established Quality Engineering , Incoming Inspection and Microbiology functions at the site. Managed the Quality Assurance Laboratory. Investigated and trended customer complaints by root cause and managed corrective action, thus ensuring effective resolution of quality issues. From May 2007 to July 2012 (5 years 3 months) Supplier Quality Engineer @ From May 2003 to May 2007 (4 years 1 month) Quality Engineer @ Contributed to the establishment and maintenance of ISO 9001 Quality System of this Multinational Medical Device Company. Ensuring Quality System compliance with internal and external requirements through the development and correct application of documents and procedures. Effectively managing a Failure Investigation and Corrective Action programme. Organising and participating in internal audits and supplier approval audits. Managing and maintaining a functional calibration system achieved by sourcing and validating a calibration software programme. Actively participating in the Quality Engineering aspects of projects and process validations. Planning, preparing and delivering training sessions in response to needs identified - Quality Standards, Quality system Requirements, GMP, auditing and calibration. From July 1993 to April 2003 (9 years 10 months) Bachelor's Degree, Quality Assurance @ Institute of Technology, Sligo From 1991 to 1993 Higher National Diploma in Analytical Methods @ Athlone Institute of Technology From 1988 to 1990 Bernadette Liddle is skilled in: FDA, Quality System, Medical Devices, CAPA, SAP, Quality Assurance, V&V, Validation, Quality Management, GMP, Supplier Quality, ISO 13485, ISO, Six Sigma, Supplier Development, Internal Audit, Supplier Evaluation, Manufacturing, Quality Control
N/A
Quality Assurance Manager
June 2014 to Present
Colchester, United Kingdom
Siemens Healthcare
Quality Assurance Manager
May 2007 to July 2014
Siemens Medical Solutions Diagnostics Manufacturing Limited
Product Quality Manager
May 2007 to July 2012
Bayer Diagnostics
Supplier Quality Engineer
May 2003 to May 2007
CR Bard
Quality Engineer
July 1993 to April 2003
What company does Bernadette Liddle work for?
Bernadette Liddle works for N/A
What is Bernadette Liddle's role at N/A?
Bernadette Liddle is Quality Assurance Manager
What industry does Bernadette Liddle work in?
Bernadette Liddle works in the Medical Devices industry.
Who are Bernadette Liddle's colleagues?
Bernadette Liddle's colleagues are Vesa Mustonen, Irmgard Van Driessche, Eric Bail, Samantha Gallagher, Kirti Vartak, Tim Lagana, Jenene Crawford, Ted Genthe, Matt Shah, and Hadi Arbabi
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