QA RA Engineer
Our client a multinational medical device company current seeks a quality engineer to join their team. Successful candidate would be required to develop specifications and inspection criteria, create and update the Quality Assurance documentation and instructions in line with the Medical Devices Directive.

Role/ Responsibilities

• Key responsibilities will include (but are not limited to) the following:
• Apply technical solutions to problem solving
• Apply technical solutions to quality improvement projects
• Use technical writing skills to clearly describe technical information
• Analyze customer complaints, identify trends and execute corrective actions
• Understand standards and their application to medical devices
• Planning, protocol generation, testing and report generation for medical devices
• Generation and maintenance of Technical Files for medical devices
• Review and update technical files in line with EU medical devices regulatory requirements
• The use ofthe GHTF STED format and harmonized standards when compiling atechnical file in compliance with the Medical Devices Directive
• Ensuring that records are filed in accordance with site procedures.
• Supporting R&D projects

Skills / Experience

• Engineering/Science qualification with 2/3 years of working within R&D/QA/RA in a medical device environment.
• 2/3 years experience in R&D, QA/RA, Validations – essential
• 2/3 years experience in Risk, Clinical and Biocompatibility – an advantage
• Excellent technical writing experience within a medical device environment - essential
• Attention to detail and accuracy – essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlookand Excel);
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.

If you would like further information you can contact: James Cassidy | Tel: +353 (0) 1 507 9250

PLEASE APPLY DIRECTLY THROUGH OUR WEBSITE FOR THIS POSITION BY CLICKING HERE

Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.
Life Science Recruitment | http://lifescience.ie

Web Presence | scientific jobs, pharmaceutical jobs, biotechnology jobs, biopharmaceutical jobs, medical device jobs, chemistry jobs, quality assurance jobs, engineering jobs, clinical research jobs, scientific sales jobs, pharmaceutical sales jobs, healthcare jobs, regulatory affairs jobs, academic jobs, connected health jobs, supply chain jobs, quality engineering jobs, diagnostics jobs, medical affairs jobs, contract jobs


Social Media | FaceBook | Twitter | Science Blog | LinkedIn