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Quality Assurance Specialist

2 months ago

Didcot, Oxfordshire, United Kingdom ResMed Full time
Quality Assurance Role at ResMed

We are seeking a highly skilled Quality Assurance professional to join our team at ResMed, a leading medical device company. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Develop and implement quality management systems to ensure compliance with regulatory requirements and industry standards.
  • Conduct audits and assessments to identify areas for improvement and implement corrective actions.
  • Collaborate with cross-functional teams to ensure quality and compliance throughout the product lifecycle.
  • Manage and maintain quality records and documentation to ensure accuracy and compliance.
  • Develop and implement training programs to ensure quality awareness and compliance among employees.
Requirements:
  • Bachelor's degree in a relevant field, such as quality assurance, engineering, or science.
  • Minimum 2 years of experience in quality assurance, preferably in the medical device industry.
  • Knowledge of ISO 13485 and EU MDR 2017/745 regulations.
  • Strong analytical and problem-solving skills, with the ability to identify and implement process improvements.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
Preferred Qualifications:
  • Project management experience, with the ability to lead and manage projects to ensure quality and compliance.
  • Experience with quality management software and systems, such as QMS or CAPA.
  • Knowledge of lean principles and six sigma methodologies.
  • Ability to think critically and make informed decisions, with a focus on quality and compliance.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.