Quality Assurance Manager

Salary, share options, pension, hybrid working and healthcare

My client are a Medical Device company im a growth stage. Dedicated to improving the quality of life for stroke patients. Developing innovative catheter-based technology to extract blood clots from the brain following an Acute Ischemic Stroke, recently received FAD approval.

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• An inclusive work environment, where all the employees are valued, supported, and encouraged.
  
• All employees have a seat at the table and have influence.
  
• A collaborative teamwork environment where learning is constant, and performance is rewarded.
  
• The opportunity to be at the forefront of a technology that can positively impact the treatment of one of the world's most devastating diseases
  

A Quality Manager you are responsible for a high level of oversight and understanding of the impact of quality processes on business needs

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• Act as Management Representative as outlined in ISO 13485:2
  
• Act as Local Actor Administrator (LAA) for EUDAMED database
  
• Reporting to top management on the effectiveness of the quality management system and any need for improvement.
  
• Manage and maintain the quality management system in compliance with the Medical Device Directive (MDD), Medical Device Regulation (MDR) EU 2017/745, the FDA Quality Management System Regulation 21 CFR 820 and ISO 13485.
  
• Promote awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
  
• Identify and manage resources required for effective functioning of QA activities.
  
• Management of internal and external audit programs as well as lead for Notified Body and FDA inspection audits.
  
• Management of Corrective and Preventive Action process
  
• Management of Risk Management activities, ensuring appropriate risk evaluations are documented to support change control activities.
  

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• Degree in Engineering, Science or health-related discipline.
  
• 7+ years’ experience in quality assurance in the medical device industry.
  
• Experienced in the support of outsourced manufacturers and suppliers to identify and mitigate supply chain risks related to quality assurance.
  
• Excellent knowledge of Good Manufacturing Practice as described in US and European regulations for medical device manufacture.
  
• Excellent knowledge of the application of ISO 14971; Risk Management, throughout the QMS
  
• Skilled in Class 8 cleanroom compliance. xcfaprz
  

Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on OR