Quality Assurance Engineer
ICDS Recruitment
Galway
Quality Assurance Engineer - Galway. My top Medical Science client is looking for someone to join their quality team. Where you'll be establishing, implementing and maintaining the Quality Systems on site. Responsibilities: Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards. Participates in new product/technology development and supports the QA activities as part of an overall project team. Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes. Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings. Partner with R&D and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective. Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality. Develops and executes required validations in line with regulatory standards to include equipment, process and product validations. Conducts root cause analysis and implements corrective action in a timely manner. Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action. Creates and maintains company quality documentation. Liaise with sterilisation and test facility to ensure sterilisation, product testing & micro requirements are achieved through out facility and that negative results are investigated and addressed in a timely manner. Liaise with R&D, Operations & Customers in the development, customization and control of product labelling. Requirements: An Engineering or Quality Assurance Degree or equivalent experience. A minimum of 3 years post qualification experience as a Quality Assurance Engineer (Med Device or similar. This is an ideal position for someone with an analytical approach to problem solving, open toexploring new ideas andworks well in a small team environment. Someone who is agood communicator, who can easily convey their ideas and requirements across all levels in the organisation. This job originally appeared on RecruitIreland.com.
2321 days ago