We are actively seeking experienced quality engineers who are ready to join a leading global manufacturer of medical devices in Tipperary.
- Identifying Manufacturing process defects (scrap, nonconforming material, customer complaints).
- Finding the primary root causes and implementing CAPAs.
- Developing Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation.
- Quality lead on Production unit and quality process improvement projects.
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
- Auditor of quality system, such as development and manufacturing, as assigned
- Key partner in forming and evaluating the production area strategy for the production unit.
- Identify & lead quality projects to support Production Area Strategy.
- Lead on Preventive Quality initiatives in Production unit.
- Technical investigation and documentation of non-conforming events and trends.
- Leads investigations on customer internal & external complaints.
- Ensure Regulatory compliance in projects.
- Analyse preliminary plans and develop reliable engineering programs to achieve company, customer and governmental agency reliability objectives.
- Develop and/or review Process Qualifications, Test Method Validations, Gage R&R’s, Process Capability studies, Design of Experiment (DOE), production control plans.
- Leads process improvement efforts by performing appropriate analysis methods to enhance sustaining product design and new product development.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Higher Level Degree qualification in Engineering/Quality/Science
- 5+ years’ experience in a Medical Device environment or related industry.
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