Sr. Design Assurance Engineer
I am delighted to be assisting my client a leading highly automated medical device plant in Limerick find a Senior Quality Engineer. The successful candidate will have experience in operational effectiveness including the initial creation of a Quality Management System. The Sr. Quality Engineer focuses on the creation of quality processes and procedures which support design control, process control & validation, supplier management and technology transfer.
My client is are known for having cutting edge, state of the art equipment onsite. This role will be perfect for someone coming from medical device, pharmaceutical, electronics, automotive industry
I have placed several candidates with this company and every person who I have place there is really happy. It has a very friendly atmosphere, down to earth team environment. They are a multinational manufacturer with a lovely SME feel. This is a great opportunity for someone looking to make a break into the Medical Device industry.
- The Sr. Quality Engineer focuses on the creation of quality processes and procedures at the which support design control, process control & validation, supplier management and technology transfer.
- The Senior Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams.
- The Sr. Quality Engineer is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry.
- As Sr. Quality Engineer you will become thoroughly knowledgeable with all aspects of quality engineering and new product development and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities.
- BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science
Certified Quality Engineering (CQE) preferred.
- A minimum of 5 years of experience working within a quality function and experience working in a FDA or ISO regulated environment.
- Robust understanding of QSR, Design Control, ISO, Product Risk Management (ISO 14971) and GMPs as defined in CFR 820 and of industry standards.
- Excellent people interaction, team building, and communication skills.