Cache of job #14061659

Job Title

Quality Assurance Engineer

Employer

ICDS RECRUITMENT

Location

WESTMEATH

Description

Quality Assurance Engineer - County Westmeath. In this role you will be responsible for: Providing Quality support to processes, materials, and products. Ensuring Quality standards are maintained, and assisting with the implementation of and compliance to the Quality Management program, and for supporting company goals, objectives, policies, procedures, quality systems, and FDA regulations. Core Duties and Responsibilities: Manufacturing Quality- • Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instructions, Validations and FMEA’s for both new product introductions and existing product line changes/process improvements. • Review and/or develop and execute facility, software, process and equipment validations and risk management documents. • Review change controls for process/design impact. • Use knowledge of statistics to assist with validation developments and process improvements. • Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines. • Assist in the analysis and resolution of problems that may reduce the efficient running of production lines. • Complete NCMR and CAPA investigation, processing and disposition. • Ensure continuous compliance for Product Manufacturing, Packaging and Labelling. • Perform Internal Audits/Supplier Audits. • Assist in the development, analysis and improvement of site Quality Metrics. • Lead/Support project activity in your area of responsibility. • Liaise with suppliers to ensure drawings and specifications are clear, understood and fully compliant. Interested applicants should have: • Degree in Engineering or Science. • At least five years’ experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments . Skills required: • Strong computer skills (MS Excel, PowerPoint, Word etc. • Familiarity with statistical tools such as Pareto charts and trend charts. • Familiarity with all aspects of Process Validation (IQ / OQ / PQ. • Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools. • Experience with problem solving techniques. • Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.

Date Added

1656 days ago

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