99945
quality Quality Engineer
Dublin North Dublin South Dublin West
Negotiable
3 - 4 Years
Permanent Full-time
Third Level Degree
Ciaran McArdle
dublin@brunel.ie
Senior Quality Engineer
Global leaders in high precision, tight tolerance, custom injection moulded products and contract manufacturing solutions organisation expanding into the medical devices arena and are seeking qualified Experienced Quality Engineers with ISO 13485 experience to help lead their new venture. Excellent opportunity for progression within an organisation with a proven track record in developing their peoples' careers.
Education/Training/Experience:
- Degree in Engineering/Science (Chemistry) discipline or equivalent.
- 3 to 5 years experience in a Senior 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.
- Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ,OQ, & PQ), cGMP, & support the generation of DMF's.
- Individual shall be a leader in this field and support the necessary validation protocols, & amendments of the quality management system in ensuring compliance with the latest FDA directives/requirements PAI readiness within the Medical Device Sector. (Proven Track record)
- Evaluation and contribution of regulatory information to applicable documents.
- Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
- Responsibility for generating Quality Performance data with the goal in identifying opportunities for improvements (CAPA)
- Support the implementation of Company Policies and GMP.
- Support External/Internal audit program.
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.
- Performance and Results driven.
To apply for this position in strict confidence, please contact Ciaran McArdle in Brunel Recruitment on +353 1 432 1510 or email your full CV to: dublin@brunel.ie
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