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Search Results for Design Assurance
Job Title. Location Salary Actions

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

QA Engineer

Role: QA Engineer (Validation) Location: Carrick on Shannon, Leitrim Benefits: Competitive salary, Bonus, pension and healthcare 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 Ensuring that product introductions & change controls are effectively managed...

Location: Leitrim, Longford, Midlands, Roscommon,
QA Engineer 		EU Not Disclosed

Senior Quality Engineer-Remote

Senior Quality Engineer-Remote Our client a startup medical device company currently seeks a Senior Quality Engineer to join their team. Reporting to Quality Engineering Manager the Senior Quality Engineer is responsible for Design Assurance and Quality Engineering support for the company’s novel medical device products. This role shall support the Quality Engineering Manager for Quality Assurance and Quality Control activities related to development, manufacturing, release, and testing of medical device products in compliance applicable device and drug regulat...

Location: Republic of Ireland,
Senior Quality Engineer-Remote 		Republic of Ireland Not Disclosed

Senior Design Assurance Engineer

Senior Design Assurance Engineer Our client a Galway based Medical Device company currently seeks a Senior Design Assurance Engineer. Reporting to the Design Assurance Manager the successful candidate will be focused on the development of new technologies Role/Responsibilities Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality...

Location: Galway,
Senior Design Assurance Engineer 		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
Scientific QA Executive Kildare Senior Quality Engineer Galway City Quality Assurance Technologist Galway Supply Chain QA Specialist Contract Quality Specialist Leitrim Engineering Manager Quality Control Manager Biotechnician QA RA Engineer Validation Specialist Dublin West Athlone Compliance Specialist Lead Quality Engineer Engineering Quality Systems Administator Quality Systems Specialist Medical Device Design Assurance Supplier Quality Engineer Meath Senior Regulatory Affairs Officer Microbiology Life Science Quality Systems Engineer Quality Auditor Connected Health Regulatory Affairs Executive Connaught Supply Chain Louth Manufacturing Coordinator Contract Validation Engineer Quality Systems Lead Technical Support Specialist Cork EHS Engineer Regulatory Affairs Clinical Research Regulatory Affairs Director Offaly Validation Scientist Life Science Technical Specialist Roscommon Leinster Regulatory Affairs Manager QA Supervisor Clinical Research Sligo QA Engineer QC Analyst Manufacturing Engineer Process Development Engineer Regulatory Affairs Midlands Manufacturing Executive Biopharmaceutical Regulatory Affairs Consultant Manufacturing and Technology Manager Validation Manager Engineering Medical Director Republic of Ireland QA Manager Biomedical Engineer Dublin Quality Assurance QE Manufacturing Engineer Laois Regulatory Affairs Specialist Pharmaceutical Medical Affairs Mayo Senior Operations Engineer Healthcare Cavan Longford Technical Support Regulatory Affairs Officer Dublin South Carlow Quality Control Supervisor Dublin North Biotechnology Dublin Greater Quality Manager Westmeath BD Manager Regulatory Affairs Quality Engineer Process Engineer QA Validation Specialist Dublin City Centre Snr Validation Engineer