Quality manager

Job Title: Quality manager

Location: MaidenheadPay 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.