Senior Technical Assurance Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeTechnical Full time €108,499 - €124,099
About the Role

This is a unique opportunity to work in our Device Development organisation as a Senior Technical Assurance Specialist. Our goal is to create better health for a better world, one person at a time.

Key Responsibilities:
  • Support and provide guidance for device development programs through the design and development lifecycle for Combination products.
  • Establish, maintain and provide guidance on the contents of Design History Files for development programs.
  • Collaborate with external partners to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
  • Support Risk Management activities for development programs through the implementation of ISO 14971:2019.
  • Maintain awareness of ongoing industry best practices, new regulations and requirements as they are developed, and implement improvement actions for the Quality Management System.
Required Skills and Qualifications:
  • Degree/Masters in engineering or science/life science.
  • Industry experience in Medical Device or Pharmaceutical (with devices).
  • Proven experience in similar level/general experience in industry.
  • Direct experience of device development and manufacturing operations activities for device or drug/device systems in a regulated environment.
  • Experience in the implementation of device design controls and regulatory requirements as applicable to device design.
  • Demonstrated understanding of GMP, Quality Management System, and relevant Regulations (e.g. 21 CFR 820, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971).
  • Strong problem solving and analytical skills.
  • Possess knowledge of core manufacturing / laboratory operation principles.
  • Excellent communication skills; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established timelines.
Benefits:

The ideal candidate will have a strong background in technical assurance and a passion for delivering high-quality results. If you are a detail-oriented professional looking to make a difference, we encourage you to apply.

What We Offer:
  • A dynamic and supportive work environment.
  • Ongoing training and development opportunities.
  • A competitive salary and benefits package.

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