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Quality Engineer - Contract
- Posted 30 November 2023
- SalaryCompetitive
- LocationCounty Westmeath
- Job type Contract
- DisciplineEngineering Leaders and Specialists, Life Sciences & Engineering Technologies
- ReferenceBBBH30066_1701363183
- ContactOlivia Rogers
Job description
Our client is a global medical device organisation based in Co Westmeath and is actively hiring for a Quality Engineer for a contract role.
The Position
You will be responsible for initiating and performing defined quality activities leading to new or improved processes or systems.
Responsibilities will include:
- Initiating and completing technical activities and cost savings as part of process improvements through the update of risk documentation, procedural updates, test methods, process/software validation etc., that have a significant impact to the business.
- Initiating, reviewing, and approving change controls.
- Performing, analysing and interpreting statistical data using an understanding of statistical tools and methods.
- Developing a strategy and implementing appropriate sampling methods.
- Write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering.
- Ensuring compliance is maintained for Product Manufacturing, Packaging and Labelling.
- Performing internal and supplier audits.
- Supporting and participating in external regulatory body audits, e.g., ISO and FDA
- Creating and analysing data for Quality Metrics.
- Complying with all relevant training required and adhering to relevant associated documentation.
- Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Following strict adherence to the requirements of CGMP.
- Actively contributing to the enhancement of compliance initiatives for areas of responsibility
The Person
- 2-3 years' experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments is preferable.
- 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 technical information, both verbally and in writing, to both non-technical and technical associates.
The Benefits
- Competitive salary.
- 9-month contract.
To discover more about this opportunity please apply online or contact Olivia Roger at HRM on +353 1 6321802 for a confidential discussion.