Our client, a medical device company in Galway are currently looking to recruit a Quality Engineer for their site.
The successful candidates will take part in multiple projects including a manufacturing transfer project which will involve Process Validation and Risk Assessment of the transferred production line and associated new equipment.
- Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities.
- Analysing quality trend data and taking appropriate action; supporting production on all quality related issues; investigating customer complaints; and ensuring an effective and robust quality system which complies with all relevant regulatory requirements.
- Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
- Develops and implements corrective/preventative action plans.
- Collects and analyzes data for gauge and product evaluation.
- Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements.
- Ensure all validation activity is effective and documented in a compliant manner.
- Complete in-depth investigations into customer complaints and implement corrective and preventative actions, as appropriate.
- Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products. Process Validation and Risk Assessment.
- Expert knowledge of blueprint reading and geometric dimensioning and tolerancing.
- Design assurance, FMEA, and product testing methods, and able to use optical comparators and CMMs.
- Knowledge of statistics, process control, and process capability.
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
Education, Experience and Skills:
- Bachelor?s degree in engineering is required or an alternative Bachelor?s degree with certification as a Quality Engineer.
- Must be familiar with Microsoft Office Suite
- Accredited certification as a Lead Auditor
- Must have minimum of 5 years of experience in Quality Engineering field
- Understanding of QSR/ISO regulations
For further information on this Senior Supply Chain Manager role in Galway please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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