Quality Engineer
Location: Waterford - Onsite
Duration: Full Time Permanent
Industry: Medical Devices
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 customer 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 initiative, decision making and be able to work in a core team environment.
Solution driven with emphasis on performance and results.
If you have any further questions, please don't hesitate to contact me on alan@accpro.ie
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance and Engineering
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Staffing and Recruiting
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