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Quality Assurance Engineer

Job Title: Quality Assurance Engineer
Contract Type: Permanent
Location: Westmeath
Industry:
REF: 95837
Job Published: about 1 month ago

Job Description

Contact: Anna McGowan
Email: recruit@hero.ie
Telephone: 0864667369

Quality Assurance Engineer

Our client, a medical device company in Westmeath is currently looking to recruit a Quality Assurance Engineer for their site.

Major Duties and Primary Responsibilities:
Manufacturing Quality
  • Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for new and existing products.
  • Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
  • Review change controls for validation 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.
  • Provide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
  • Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
  • Perform Internal Audits.
  • Assist in the development, analysis and improvement of site Quality Metrics.
  • Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
  • Will comply with all relevant training required and adhere to relevant associated documentation.
  • Follow strict adherence to the requirements of CGMP.
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.

Requirements:
  • Degree in Engineering or Science or minimum 5 years’ experience in a Medical Device environment.
  • Five (5) years’ experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.

Skills:
  • Strong computer skills (MS Excel, PowerPoint, Word etc)
  • Familiarity with statistical tools such as Pareto charts and trend charts.
  • 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.

For further information on this Quality Assurance Engineer role in Westmeath please contact Anna McGowan on 0864667369 / recruit@hero.ie

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