Are you an experienced Quality Engineer ready to join a medical devices leader that changes lives?
Act as a member of the Cork facility Quality Team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
- Supervision of Quality Technicians.
- Drive and implement process and quality system improvements.
- Provide effective and responsive QA support to Operations.
- Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
- Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
- Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Compilation of required Regulatory documentation.
- 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.
- Minimum of Bachelor of Science Degree in Engineering/Technology
- 2+ 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.
For a confidential discussion please reach out to Jakub on 021 2359 140 or email@example.com
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