Quality Assurance Engineer
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Job title: Quality Assurance Engineer
Location: Ballinasloe, Galway
Benefits: Excellent salary, pension, healthcare yearly bonus, 4 day working week.
Job overview:
The Quality Assurance Engineer is a key member of the Quality team charged with establishing, implementing and maintaining the Quality System on site.
Responsibilities:
? Partner with R&D and Process Engineers to ensure that the transition of products through R&D and sister sites, product approval and manufacturing scale up are smooth
? 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
? Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
? 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.
? Deals with suppliers and ensures their quality standards are in line.
? Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required.Qualifications
? An Engineering or Quality Assurance Degree or equivalent experience.
? A minimum of 3 years post qualification experience as a Quality Assurance Engineer within a Medical Device or regulated environment.
If you are interested in hearing more about this opportunity or others like it across Ireland contact me at anytime via email or call and I happy to discuss the market further.
Look forward to hearing from you. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales