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Quality manager

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Job Description - Quality manager

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.

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