Job Description
Design Assurance Engineering Consultant
Our client, a fast growing international consulting group, now seek an experienced Design Assurance Engineer for their permanent role, who will work on a consultancy basis in representation of the company and management of nominated medical devices client.
The successful candidate will be integral to the success of client's key projects in New Product Development and New Product Introduction, from a Design Assurance perspective.
The ideal person fit will be a self-starter, with an entrepreneurial mind-set, capable of working independently and as part of a team.
This permanent role will be based in Galway. Similar positions are available in; Athlone, Dublin and Cork.
The successful candidate will be integral to the success of client's key projects in New Product Development and New Product Introduction, from a Design Assurance perspective.
The ideal person fit will be a self-starter, with an entrepreneurial mind-set, capable of working independently and as part of a team.
This permanent role will be based in Galway. Similar positions are available in; Athlone, Dublin and Cork.
Scope of this role:
Ownership / design assurance responsibility for a portfolio of products for nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business in the definition of the design assurance / product development process, in line with agreed timeframes.
This project work will include:
? All activities pertaining to the design, development and qualification of new products for the nominated medical devices client / customer.
? Formulating quality strategy through the product development process - regulatory compliance, risk management, design control and quality systems - ensuring Product Development meets all applicable regulatory requirements.
? Lead management of the client / customer product development systems and associated project teams, promoting and effecting compliance to; quality, business and health & safety systems and market/legal regulation.
? Coordinating and prepares product submissions to obtain global approvals for commercial distribution.
? All activities pertaining to the design, development and qualification of new products for the nominated medical devices client / customer.
? Formulating quality strategy through the product development process - regulatory compliance, risk management, design control and quality systems - ensuring Product Development meets all applicable regulatory requirements.
? Lead management of the client / customer product development systems and associated project teams, promoting and effecting compliance to; quality, business and health & safety systems and market/legal regulation.
? Coordinating and prepares product submissions to obtain global approvals for commercial distribution.
Requirements for Design Assurance Engineering Consultant:
Bachelor's Degree in Science, Engineering or equivalent technical discipline.
5+ years' experience in regulatory compliance or quality assurance role involving NPD and NPIs.
Project management skills with the ability to oversee multiple projects simultaneously.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Proven Quality Systems knowledge and experience to FDA regulatory guidelines.
A proactive approach with the ability and experience to manage a diverse team of professionals
Excellent written and oral communication skills, particularly with client management and competent authorities.
Demonstrate professionalism and leadership at all times.
Flexible and willingness to adapt with business requirements.
Please contact Larry on 01-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. http://www.rftgroup.ie
Key words; New Product Development, NPD, NPI, Design Assurance Quality Systems, Commercial Launch, Design Engineering, Medical Devices, Galway, Clare, Athlone, Connaught, Dublin, Cork.