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Excellent role for a Quality Engineer in a leading medical devices company based in Waterford City.
Reporting to the Senior Quality Engineer the Purpose of the 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 conforms 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 include:
- 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.
- 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.
- 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.
The ideal Candidate will have:-
- Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
- 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. (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.
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