Quality Engineer

Gemma Hayes Recruitment1

Waterford

Title: Quality Engineer. Department: Quality. Reports to: Senior Quality Engineer. Education/Training/Experience: • Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline. • 3 to 5 years’ experience in a Quality Engineering role. • Fully competent in Quality Management Standards. Responsibilities of Position: • 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. • 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. 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.

2491 days ago