Job Title: Quality manager Location: Maidenhead Pay rate: 70k-75k Primary Objective of Position Responsibility for compliance with Abbott/ ADC Commercial Quality System (QS) and local laws and regulations Ensures Quality System effectiveness through implementation and maintenance of respective procedures and processes Assurance that all relevant requirements are met prior to distributing product in the countries/region incl. product labelling with country regulations Major Accountabilities Maintains and implements the EMEAP Multisite Integrated Management System (MIMS)/ ADC Commercial Quality System and its compliance at Affiliate/ Regional level according to applicable policies/ procedures and regulations Supervision and control of compliance with quality procedures, incl. implementation, training, and documentation Provides expert quality advice and supports commercial/ business processes regarding quality aspects, incl. e.g. launches and/ or other commercialization projects/ processes Plans and conducts internal audits to verify the effectiveness of the management system Prepares and coordinates external audits Effectively executes key quality processes e.g., Management Reviews, Supplier/ Distributor/ Warehouse Control, CAPA, Promotional Materials, Quality Hold, Document Control and Record Keeping according to established and/or newly developed procedures (e.g. OneAbbott) and supports further developments Performs evaluation, re-evaluation and monitoring of suppliers/ distributors/ warehouses. Evaluate Third-Party Warehouses and Distributors with respective on-site audits (as appropriate) Support of medical event reporting and field actions in close cooperation with Product Quality Assurance (PQA), Customer Service, Regulatory Affairs and Vigilance/ Medical Event Group (MEG) Supports local complaint handling/ product replacement process and related aspects e.g., with relevant partners/ functional ADC units like PQA and represent respectively within the Affiliate Management Team Prepares/ supports updates to Personnel related documents such as organization chart, job description and training plans Ensures QS training programs in that all relevant employees are trained, and records maintained Initiates, supports, and participates in Quality System improvements and implementation projects Education Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) Background Preferably 3-4 years of experience in the Medical Device Industry in the area Quality/ Regulatory Affairs or equivalent experience/ knowledge of regulatory requirements and applicable quality standards Solid technical understanding/ scientific knowledge of products Excellent organization skills; project management experience are a sur-plus Knowledge of PC-based applications, such as Microsoft Office High Proficiency in English language Impact of position Successful implementation of quality processes and compliance assurance with Abbott's quality procedures and regulations Supports Affiliate/ Regional management to ensure compliance with quality policies, procedures, and requirements regarding commercial/ business processes Quality Representative for Affiliate/ Region Randstad Business Support is acting as an Employment Business in relation to this vacancy.