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Expert Technical Assurance Professional

2 weeks ago

Galway, Galway, Ireland beBeeDesign Full time €60,000 - €90,000
Job Description

Our client, a Galway-based Medical Device company, is currently seeking an experienced professional to fill the role of Senior Design Assurance Engineer. The successful candidate will report to the Design Assurance Manager and focus on the development of new technologies.

The role involves working within the quality system to ensure compliance with relevant regulatory requirements, including Medical Device Directive 93/42/EEC, 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820, FDA GLP Regulation 21 CFR § 58, FDA Labelling Regulation 21 CFR § 801, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.

The Senior Design Assurance Engineer will provide design assurance input to R&D project teams, understanding regulatory requirements and incorporating them into projects. This will involve leading specification development, generating Design Input/Output documents, and participating in Design Reviews and checklists.

Key Responsibilities
  • Work within the quality system to ensure compliance with regulatory requirements.
  • Support development and evolution of Design Control, Risk Management, and related systems for new product development technologies.
  • Provide design assurance input to R&D project teams.
  • Lead specification development and generate Design Input/Output documents.
  • Participate in Design Reviews and checklists.
  • Design, develop, and validate test methods to support development programs.
  • Develop and maintain design verification and validation plans, protocols, and reports.
Required Skills and Qualifications

The ideal candidate will have a degree in Engineering, Science, or a related field, and over 5 years of relevant experience in the medical device or pharmaceutical industry. They should also have a strong understanding of ISO 13485, ISO 14971, and FDA QSRs, as well as familiarity with statistics, validation, and physical testing.

Benefits

This is a great opportunity for an experienced professional to join our team and contribute to the development of new technologies. We offer a competitive salary and benefits package, as well as opportunities for growth and development.

How to Apply

If you are interested in this exciting opportunity, please submit your application through our website. We look forward to hearing from you