Quality Manager

Quality Manager

Posted Mar 20 2019

UK or US Remote

Full time

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What will you do

You will develop and maintain the quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of our product conforms to established internal and external standards and guidelines. You will be involved in every stage of the product life cycle, deploy it out into the wild and see its positive impact on real people.
You will use your expertise and help guide your colleagues in interpreting policies, external regulations, and internal regulations to assure compliance. Take the lead on audits and inspection preparation, ensure successful resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.

You will prepare reports and documentation ensuring the Quality Management System is kept up to date and compliant with all changes and developments in the product.
You will be responsible for ensuring all employees are trained in the Quality Management System and be the first line support on all things Quality related for all teams including Customer Support, Software, Hardware and Data Science.

About you

  • Have proven experience in Quality Systems and Regulatory Environment
  • Working knowledge of ISO 13485, FDA Quality System Regulations and the Medical Device Directive (93/42/EEC)
  • Be a Certified Internal Auditor
  • Have strong experience in Regulatory Affairs and/or Quality with demonstrated experience in the full range of submissions and in dealing with local and international regulatory agencies including the FDA
  • A BSC degree or equivalent in a Life Sciences field would be ideal
  • You are flexible and can learn on the job quickly
  • It is important you can pragmatically balance quality with a fast-paced schedule
  • You are a good team player, ready to help, debate, compromise and work together
  • You are comfortable working, prototyping and delivering incrementally, adapting based on customer needs and technical difficulties, always with the user in mind
  • Have the ability to work with people across all levels and teams
  • You have an eye for detail
  • You always look at the big picture
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