Quality Engineer
4 weeks ago
- Leading Pharmaceutical Company in the West of Ireland
- Excellent career progression opportunities along with a generous package
- Champion continuous process improvement in conjunction with other functions
- Analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
- Establish inspection plans, frequencies and test methods for incoming material/parts.
- Overall responsibility for GMP standards and compliance within the manufacturing area
- Drive risk management activities in manufacturing
- Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment.
- Manage assigned aspects of the quality system in compliance with ISO 13485:2003, 2012. FDA QSR, MHLW and Canadian Quality System requirements.
- Conduct internal audits as defined by audit schedules.
- Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager.
- Higher Level Degree qualification in Engineering/Quality/Science with a minimum 5 years' experience in a Medical Device environment or related industry.
- Demonstrate strong leadership skills, communication skills and promote quality at source.
- Excellent interpersonal and communication skills with good leadership abilities
- Experience of direct interaction with Regulatory Bodies (e.g. HPRA, FDA)
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