Quality Engineer required by leading FDA manufacturing company based in Waterford City. Reporting to the Quality Lead the overall purpose of this role is
* The Quality Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses.
* Ensures 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.
* May investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies.
* Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.
Key Responsibilities and End Results
(Essential responsibilities include but are not limited to the following):
* 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.
* Individual with an experienced background in sterilisation, automation, equipment/software validation.
* Individual with an experienced background in manufacturing within controlled environments.
* Individual shall support the external & internally Quality Management System auditing function (auditor trained).
* Individual shall have exposure & involvement in supporting the CAPA system.
* Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
* Support the implementation of Company Policies and GMP.
* Support all company safety and quality programs and initiatives.
* Ensure ongoing compliance with GMP in all practices, recording of events and processes.
* Ensure compliance with all learnings from all GMP training events.
* Root cause problem solving approach in a team environment.
* Aligning customer specification to company capabilities.
* Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Job Specifications
The minimum education and experience required to perform this job competently.
* Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
* 2 to 4 years’ experience in a Quality Engineering role.
* Fully competent in Quality Management Standards.
* Skills/Attributes:
* Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
* 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.
Skills
* ISO13485
* CAPA
* QA
* PFMEA
* GMP
Benefits
* pension
* Healthcare
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