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Search Results for Design Assurance
Job Title. Location Salary Actions

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Specialist 		EU Not Disclosed

Principal Scientist Device and Product Performance

Principal Scientist, Device and Product Performance Our Dublin based client are currently recruiting for two highly skilled Principal Scientist, Device and Product Performance to join their team on a permanent basis. In this role, you will lead the design, development, and performance evaluation of drug-device combination products, ensuring they meet regulatory and quality standards. Your expertise will drive technical excellence, innovation, and patient-centric solutions. Responsibilities Provide subject matter expertise to support the development of Combination...

Location: Dublin,
Principal Scientist Device and Product Performance 		Dublin Not Disclosed

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Specialist 		EU Not Disclosed

Quality Specialist

Job title: Quality Assurance Specialist Location: Western Business Park, Shannon, Co. Clare Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept. Summary: The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes m...

Location: Clare, Limerick, Limerick City, Republic of Ireland,
Quality Specialist 		EU Not Disclosed

Senior Project Engineer

Job title: Senior Project Engineer Location: Cootehill, Co. Cavan Company: My client are a global healthcare leader that helps people live more fully at all stages of life. With a portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Role: You will work within the Packing Department Projects division joining an established team of Engineers in the delivery of improvements to help integrate new products or processes i...

Location: Cavan, Fermanagh, Longford, Midlands, Roscommon,
Senior Project Engineer 		EU Not Disclosed

Senior Project Engineer

Job title: Senior Project Engineer Location: Cootehill, Co. Cavan Company: My client are a global healthcare leader that helps people live more fully at all stages of life. With a portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Role: You will work within the Packing Department Projects division joining an established team of Engineers in the delivery of improvements to help integrate new products or processes i...

Location: Cavan, Fermanagh, Longford, Midlands, Roscommon,
Senior Project Engineer 		EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working Company: Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training. Responsibilities Assist with the implementation and development of the site QMS in line with the ...

Location: Athlone, Connaught, Leitrim, Longford, Midlands,
Quality Engineer 		EU Not Disclosed

Software Design Assurance Engineer

Software Design Assurance Engineer Our client in Dublin are looking to add a Software Design Assurance Engineer to their growing team. Our client are a global medical technology company founded to establish bimodal neuromodulation as a new standard of care for tinnitus, a condition that affects 15% of the global adult population. Main Purpose and Objective of the Position: You will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software. ...

Location: Dublin, Dublin City Centre, Dublin South,
Software Design Assurance Engineer 		Dublin 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