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€45,000 - €55,000
18 Jun 2021
A leading Medical Device manufacturer in Cork is seeking multiple
Senior Quality Engineers
due to expansion. Working on multiple projects and technologies you will bring your expertise in Quality Engineering, particularly in Validation, for New Product Introductions and Tech Transfers. On offer are roles that can be either permanent or contract and attractive salaries and hourly rates are available and a hybrid working model with 2-3 days WFH.
About the Jobs:
Represent Quality as part of a cross functional team to ensure delivery of projects into production with the highest level of quality, compliance, and adherence to timelines.
Validation & Test Method Validation experience required.
Compile and execute validation protocols for new product/processes and software
Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
Liaise with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development
Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
Lead QA input to Design for Manufacture activities on site.
Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during all day to day
Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.
About the Ideal Candidate:
A degree level or similar qualification in mechanical or industrial engineering.
Strong experience in a quality role within a regulated industry.
Proven ability to successfully introduce new product development in the Medical Device Industry.
Proven knowledge and ability regarding product verification and process validations.
Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
Proven experience and training in Mechanical Engineering processes.
For more on the roles call Nigel on 087 3618142 or send your CV for consideration.