Quality Engineer - County Waterford
Ref No: AM18368
Job Summary:
* The Quality Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses.
* E nsures that performance and product quality conform to established company, customer and regulatory requirements.
* Assists in the review, analysis and reporting on quality discrepancies related to assembly and process.
* M ay investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies.
* I interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.
Main Responsibilities:
* Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
* Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's & support the generation of DMF's where appropriate.
* Uses scrap reduction methodologies and process capability analysis to provide a robust defect free process.
* Ideally experience in sterilisation, automation, equipment/software validation.
* Ideally experience in manufacturing within controlled environments.
* Support the external & internal Quality Management System auditing function (ideally auditor trained).
* Ideally will have exposure & involvement in supporting the CAPA system.
* C lose liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
* S upport the implementation of company policies and GMP.
* S upport all company safety and quality programs and initiatives.
* E nsure ongoing compliance with GMP in all practices, recording of events and processes.
* E nsure compliance with all learnings from all GMP training events.
* R oot cause problem solving approach in a team environment.
* A ligning customer specification to company capabilities.
Requirements:
* Degree in Engineering / Science or similar discipline.
* At least 3 to 5 years' experience in a Quality Engineering role.
* Fully competent in Quality Management Standards.
* Excellent Leadership skills, ability to motivate team members within the organisation.
* Excellent organisation, communication, computer & presentation skills.
* Excellent initiative, decision making and be able to work in a core team environment.
* Solution driven with emphasis on performance and results.