The Quality Engineer will provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
- Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).
- Drive and implement process improvements to ensure predictable processes across all product lines.
- Provide effective and responsive QA support to Operations to meet objectives.
- Ensure all process variables and their interactions are adequately defined.
- Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's).
- Drive and implement plant wide quality system improvements.
- Provide functional expertise to other support functions on quality related issues.
- Identification and implementation of appropriate statistical techniques to monitor process performance.
- Review, assessment and approval of change notices for product, process and quality system changes.
- Customer complaints: analysis of complaint trends.
- Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- MRB: Review of MRB trends and identification of appropriate corrective actions when required.
- Perform internal quality audits.
- Support the implementation of Lean Manufacturing across the site.
- Transfer and implement product and processes from development or from another manufacturing facility and support introduction of new products.
Qualifications and Requirements
- Minimum of Bachelor of Science Degree in Engineering/Technology
- 2-5 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
What you need to do
If your experience matches the above criteria please register via Kelly Services today, and click apply or call Niall Curley on 353-864113572 for a confidential conversation today.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.