Senior Quality Assurance Engineer

7 days ago


Bedford, Bedford, United Kingdom SPD Development Company Limited Full time
About the Role

We are seeking a highly skilled Senior Quality Assurance Engineer to join our Quality team at SPD Swiss Precision Diagnostics GmbH. As a Senior Quality Assurance Engineer, you will be responsible for ensuring the quality and compliance of our medical devices, including product design and development, product changes, concept innovation, and new product initiatives.

Key Responsibilities
  • Develop and implement quality systems and processes to ensure compliance with regulatory requirements, including ISO 13485, Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, US FDA 21 CFR Part 820, and IEC 62304.
  • Lead quality assurance activities for software as a medical device and design control for in-vitro diagnostic devices.
  • Collaborate with cross-functional teams to ensure quality and compliance throughout the product lifecycle.
  • Develop and maintain quality procedures, work instructions, and training programs.
  • Conduct audits and assessments to ensure compliance with regulatory requirements.
  • Identify and implement process improvements to enhance quality and efficiency.
Requirements
  • Proven experience in quality assurance and regulatory compliance in the medical device industry.
  • Strong knowledge of ISO 13485, Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, US FDA 21 CFR Part 820, and IEC 62304.
  • Experience with quality assurance of software as a medical device and design control for in-vitro diagnostic devices.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
What We Offer
  • Competitive salary and benefits package.
  • Opportunity to work with a world-leading company in the medical device industry.
  • Collaborative and dynamic work environment.
  • Professional development and growth opportunities.


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