Quality Engineer- Equipment
Job ID: JOB-11909
Quality Engineer- Equipment
Our client, a global leader in Medical Devices are looking to attract a Quality Engineer to join their team in Galway. This role is commutable from Mayo, Limerick & Clare.
- Act as a technical resource within the Mechanical Test lab for review, approval and resolution of non-conformities.
- Acts as a team member in supporting quality decisions, and practices.
- Ensures that New equipment validations are carried out in compliance with site/corporate policies and SOPs. Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
- Understands and complies with all the regulations governing the quality systems.
- 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 are fully compliant with site/corporate policies and SOPs.
- Initiate Equipment Risk Assessments along with associated documentation for equipment and systems.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Lead and/or support continuous improvement projects, CAPA and LEAN initiatives.
- 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.
- 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.
- Preferred knowledge an advantage 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.
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Apply Now Job ID: JOB-11974 IT Systems Administrator My pharma client based in County Galway are looking to hire an…
Apply Now Job ID: JOB-11973 Regulatory Affairs Specialist Permanent Job Purpose: As a Regulatory Affairs Specialist, you will be a…
Apply Now Job ID: JOB-11861 Staff Lean/Continuous Improvement Engineer Our client, is recruiting for a Staff Lean/Continuous Improvement Engineer to…