Job Description
Quality Engineer - County Waterford
Ref No: AM18368
Located in County Waterford, Republic of Ireland
Competitive salary and benefits package
Job Summary:
* The Quality Engineer plays a key role in the development and implementation of quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. Ensuring that performance and product quality conform to established company, customer, and regulatory requirements.
* Provides technical support during the NPI process, ensuring that all FDA, QSR, and MDD standards are achieved and maintained for device classifications.
* Fully competent in the application of quality engineering tools and techniques, with an emphasis on validation protocols (DQ, IQ, OQ, and PQ), cGMP, PFMEA's, and supporting the generation of DMF's where appropriate.
* Uses scrap reduction methodologies and process capability analysis to provide a robust defect-free process.
* Ideal candidate will have experience in sterilization, automation, equipment/software validation, and manufacturing within controlled environments.
* Supports the external and internal Quality Management System auditing function and is ideally auditor trained.
* Closely liaises with other departments to provide and drive quality inputs and initiatives into operational activities.
* Ensures ongoing compliance with GMP in all practices, recording of events, and processes.
* Promotes a root cause problem-solving approach in a team environment.
* Aligns customer specifications with company capabilities.
Requirements:
* Degree in Engineering or Science or similar discipline.
* At least 3-5 years' experience in a Quality Engineering role.
* Proficient in Quality Management Standards.
* Excellent leadership skills, ability to motivate team members.
* Strong organisational, communication, computer, and presentation skills.
* Solution-driven with emphasis on performance and results.