Abbott Senior Specialist Quality in Maidenhead, United Kingdom
Primary Objectives of Position
Supports Quality System compliance in Region North (UK, Ireland and Nordics)
Supports a specific process or processes for the whole EMEAP as Subject Matter Expert
Supports the Manager QA Region to ensure EMEAP and Region Quality System effectiveness and compliance:
Performs internal and supplier audits.
Supports / prepares/ coordinates external audits.
Supports QS processes: e.g. Field communications, supplier evaluation, audits and CAPA, AdPromo, document control and record keeping.
Review & approve locally developed AdPromo material in local language on behalf of Regulatory Affairs. Undertake training by RA and the QA AdPromo SME.
Supports the EU/ EMEAP Quality System.
Responsible for specific processes in collaboration with the QA team SME e.g. Field communications, supplier evaluation, competence management, distributor management.
Participates in Quality System improvements and implementation projects.
MIMS Subject Matter Expert & Procedure Owner:
Review Abbott policies & procedures, and update Quality documentation accordingly.
Receive audit input and follow QS Document Control Process.
Supports commercial organization in contracts and public tenders (QARA, EHS requirements) in collaboration with the QA team SME, RA and EHS
Scientific background (i.e. Lab Technician, Biology, Chemistry, Pharma, M.D.) preferred. Other education is acceptable with relevant experience.
Demonstrated experience in the diagnostic industry (commercial affiliate or manufacturing)/clinical laboratory/ Competent Authority/ IVD industry association.
Quality Assurance experience is essential from a medical device or pharmaceutical company
Knowledge of ISO 9001 is advantageous
Experienced working in international environment/ projects. Cultural sensibility.
Impact of position
Operates under Quality and Regulatory directives and Abbott policies and procedures.
Follows local regulations and international industry/ Quality System standards.
The position will involve occasional travel
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org