Quality Assurance Specialist

1 month ago


Didcot, Oxfordshire, United Kingdom ResMed Full time
Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our Quality Assurance team in our Didcot office. As a Quality Assurance Specialist, you will play a critical role in ensuring that our management systems are established to enable business compliance, multiple regulatory frameworks, and to support the design, development, and manufacture of products that meet our customer's quality requirements.

Key Responsibilities:
  • Support the implementation of the Quality Management Systems (QMS) in EMEA, ensuring compliance with applicable regulatory standards and requirements.
  • Manage quality activities and actions within the framework of the QMS, ensuring the implementation of procedures and processes necessary for compliance.
  • Contribute to reviewing, analyzing, and implementing opportunities for continual improvement of the QMS, quality documents, and records.
  • Support the response to audit findings and CAPAs in EMEA.
  • Conduct quality audits of suppliers and service providers, ensuring compliance with company and external regulatory agency requirements.
Requirements:
  • Bachelor's degree or Master in Science, Quality, or Engineering.
  • Minimum 2 years of applied professional quality assurance experience, ideally including the medical industry.
  • Experience with ISO 13485 Medical Standard and knowledge of EU MDR 2017/745 & local regulations.
  • Strong planning and organization skills, as well as strong listening, verbal, and written communication skills.
  • Ability to work remotely and effectively with remote teams, building and maintaining positive relationships while influencing change.
Preferred Qualifications:
  • Ability to identify linkages and dependencies between processes.
  • Experience in the maintenance of Management Systems, including ongoing improvement of systems and processes.
  • Project management experience.
  • Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.

We offer a competitive bonus plan, working from home flexibility, and access to a referral bonus and ResMed's preferred shareholding programme. Join us and discover a career that's challenging, supportive, and inspiring, where a culture driven by excellence helps you not only meet your goals but also create new ones.



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