Based in Waterford
Are you an experienced Quality Engineer looking for your next move?
A fantastic opportunity for an experienced Quality Engineer with pharmaceutical or medical device experience to join an expanding manufacturing facility in Waterford.
You will be responsible for development and implementation of quality plans, for exciting NPI products being introduced to the site. You will also assist in the review, analysis and reporting on quality discrepancies related to assembly and process.
What is in it for you?
- This is a great opportunity to expand your skillset in this fast moving, dynamic and agile business.
- Excellent opportunities for career progression and advancement. My client trains, develops and supports their people with clear career paths and promote internally where possible
- Attractive salary and benefits package on offer
- Friendly, inclusive and collaborative working environment. Team work, new ideas and ''thinking outside the box'' is very much encouraged
- 'Family feel'' culture but has the support of a larger global organisation
- Onsite parking and canteen facilities
- Days only role - with flexible working hours
The successful candidate will have a relevant third level qualification with a minimum 3 years' experience within the pharmaceutical or medical device industry.
- 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.
- 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.
Click Apply now to review the full details and job spec for this amazing opportunity or contact Kerry on 0860443981 for an informal chat.