About Your New Employer
This is an exciting opportunity to take the next step working with a Medical Device company in Galway that has been ranked as one of the best places to work by countless publications in the past few years. Your job as Quality Engineer I/II (Mechanical Test Lab) will give you the opportunity to see this in action and give you the opportunity to make a difference in people's lives.
About Your New Job
- You will act as a technical resource within the Mechanical Test lab for review, approval and resolution of non-conformities.
- You'll be a team member in supporting quality decisions, and practices.
- Ensure that new equipment validations are carried out in compliance with site/corporate policies and SOPs, you will demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
- Understand and comply with all the regulations governing the quality systems.
- It is your job to evaluate new equipment and to support testing for IC, PI and Endo Divisions.
- You will support new product testing and equipment transfer into the Galway lab.
- Create, review and approve new documentation, including test methods, work instructions and validation documents.
- You will ensure that Calibration and Maintenance for existing and new equipment are fully compliant with site/corporate policies and SOPs.
- You Initiate Equipment Risk Assessments along with associated documentation for equipment and systems.
- Evaluate in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Lead and/or support continuous improvement projects, CAPA and LEAN initiatives.
What You Need
- A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
- 2-3 years experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
- Effective communication skills to effectively communicate timelines and changes in project milestones.
- Interfaces with lab customers and vendors including Operations, NPD, Sustaining and OEMs.
- Knowledge of Mechanical test methods such as: Leak, Burst, Tensile, Particulate, Lubricity, Tracking, Optical Measurement & Torsion testing
- Demonstrate a primary commitment to patient safety and product quality.
What's on Offer
In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:
- 10% Annual Bonus
- Fully covered Health Insurance for you and your family
- Pension Scheme
- Stock Ownership Programme
- Paid Maternity Leave
- Career Progression Opportunities
Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E: email@example.com
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