Our client a medical device company located in Tipperary requires a permanent QE. This role requires an experienced candidate who can provide support to manufacturing, helping to ensure delivery of highest quality product to the customer and support to product development teams, helping to ensure development of highest quality new products.
- Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
- May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
- Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
- May be responsible for creating risk analyses and FMEAs.
- Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
- Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
- Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
- Could serve as auditor of quality system,
- Responsible for the final Process Monitor Release for products prior to distribution.
- Engineering Level 8 or above
- 2-3 years in an Engineering\Science position in a Medical Device environment or a regulated environment.
- Excellent interpersonal and communication skills. Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
- Experience/training in problem solving and process improvement methodologies. (Engineering Essentials TM).
For further information on this Quality Engineer role in Tipperary please contact Cliona O'Malley on 091730022 / email@example.com
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