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Search Results for Design Assurance
Job Title. Location Salary Actions

Associate Director Computer Systems Quality Assurance & Data Integrity

Associate Director Computer Systems Quality Assurance & Data Integrity Our client, a global biopharmaceutical manufacturer are currently recruiting an experienced Associate Director to lead Computer Systems Quality Assurance (CSQA) and Site Data Integrity efforts at a next-generation manufacturing site. Responsibilities: Lead quality oversight for GxP computerized systems across manufacturing, labs, IT, and logistics Implement and maintain data governance and computer system validation (CSV) strategies Ensure compliance with global standards (e.g.%2...

Location: Limerick,
Associate Director Computer Systems Quality Assurance & Data Integrity 		Limerick Not Disclosed

Principal Scientist/Engineer Medical Device Development

Principal Scientist/Engineer Medical Device Development Our Dublin based client are currently recruiting for a highly skilled Principal Scientist/Engineer to join their Device and Product Performance 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 C...

Location: Dublin,
Principal Scientist/Engineer Medical Device Development 		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

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