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Search Results for Design Assurance
Job Title. Location Salary Actions

Project Manager Design Assurance

Job title: Design Assurance Program Manager Location: Ballybrit Upper Industrial Estate, Galway Benefits: Hourly rate contract, 3 days a week (Partime), Hybrid working Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and component technologies. Responsibilities: • Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record docume...

Location: Galway, Galway City,
Project Manager Design Assurance 		Galway Not Disclosed

Design Assurance Program Manager

Job title: Design Assurance Program Manager Location: Ballybrit Upper Industrial Estate, Galway Benefits: Hourly rate contract, 3 days a week (Partime), Hybrid working Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and component technologies. Responsibilities: • Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record docume...

Location: Galway, Galway City,
Design Assurance Program Manager 		Galway Not Disclosed

Design Assurance Program Manager

Job title: Design Assurance Program Manager Location: Ballybrit Upper Industrial Estate, Galway Benefits: Hourly rate contract, 3 days a week (Partime), Hybrid working Company: My client are a global leader in the medical device industry and expert in the design, development, and manufacturing of complex medical devices and component technologies. Responsibilities: • Lead Quality Representative on projects, directly contributing and/or providing guidance to others to establish appropriate Design History File / Device Master Record docume...

Location: Galway, Galway City,
Design Assurance Program Manager 		Galway Not Disclosed
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Design Assurance Career Profile

Design Assurance


Design Assurance engineers provide quality support to R&D and assist in the scale up and commercialization of product.

Role/Responsibility

  • Support risk management activities
  • Evaluation of new products, assuring the safety and efficacy of the devices
  • Design verification and shelf life protocols / reports
  • Qualification and validation activities
  • Knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
  • Adhere to Quality System and Design Control requirements
  • Root cause investigations; drive problem solving efforts for quality issues
  • Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
  • Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
  • Support customer complaint analysis and post market surveillance activities
  • Generate and approve change requests

Skill/Experience

  • Bachelor's Degree in Engineering or Science related Discipline (Master's Degree desirable)
  • A minimum of 2 years experience, with at least 1 years experience in the Medical Device industry
  • A minimum of 1 years experience in product & process development