Our client, a medical device company in Galway are currently looking to recruit a Quality Engineer - Mechanical Test Lab for their site.
Develops, establishes and maintains engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality and Engineering representative to improve awareness, visibility, communication on Quality and Engineering initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused Quality and Engineering support within the Mechanical test lab to support new product and process development, Equipment and process integration, Validation testing, Site operational test support and Quality system/services support.
- Act as a technical resource within the Mechanical Test lab for review, approval and resolution of non-conformities within the laboratory.
- Acts as an team member in supporting quality decisions, and practices.
- Ensures that New equipment validation is carried out in compliance with site/corporate policies and SOPs.
- Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
- Evaluates new equipment to support testing for IC, PI and Endo Divisions.
- Supports new product testing and equipment transfer into the Galway lab.
- Creates, Reviews and approves new documentation, including test methods, work instructions and validation documents.
- Ensures that Calibration and Maintenance for existing and new equipment’s are fully compliant.
- Initiate Equipment Risk Assessments along with associated documentation for equipment and systems.
- Must be an effective communicator to effectively communicate timelines and changes in project milestones.
- Interfaces with lab customers and vendors including Operations, NPD, Sustaining and OEMs.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Understands and complies with all the regulations governing the quality systems.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Preferred knowledge an advantage of Mechanical test methods such as: Leak, Burst, Tensile, Particulate, Lubricity, Tracking, Optical Measurement & Torsion testing.
- Lead and/or support continuous improvement projects, CAPA and LEAN initiatives.
- Demonstrate a primary commitment to patient safety and product quality.
Qualifications & Experience
- HETAC Level 8 qualification in a STEM subject with a minimum of 2-3 years relevant work experience.
- Demonstration of problem solving and/or project management skillsets and application.
- Good technical capabilities, communication skills and organisation skills.
- Demonstration of taking initiative to drive improvement and change.
- Proven ability to work well with teams but also with minimum supervision.
For further information on this Quality Engineer - Mechanical Test Lab role in Galway please contact Orla Crowley on 086 0449473 / firstname.lastname@example.org
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