Senior Quality Engineer
Senior Quality Engineer
I am delighted to be assisting my client a leading medical device company in Dublin recruit a Senior Quality Engineer. The successful candidate will have experience in new product development and ongoing product life cycle technical and engineering support. The Senior Quality Engineer will manage projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
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 industry with 3 - 5 years' experience in a similar role.
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.
You will have the opportunity to:
- Apply extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / confirmed results.
- Write and leads risk management activities including risk management reports and risk analysis.
- Investigates product and process issues, helping to determine root cause, and establishing effective corrective action.
- Support and provide training for product development teams, continuous improvement teams, and manufacturing plants on best practices.
- Be a SME and lead audits as member of a quality system audit team.
- Position specific responsibilities include support of the following, however, are not limited to: Design Control, Change control, Risk Management, Process Validations, Identification of CTQ's, Unit Quality Independent Reviewer During Design Reviews, Handling of deviations and non-conformances, Test method validations, Supplier qualification, Software validations, Post Market Surveillance, Situation Analysis, CAPA Root cause investigation and implementation of corrective / preventive actions, Proper Use of Statistics (Sampling Plans), Advise on Regulations, Liaise with Manufacturing Plants, Provide functional support to cross-functional teams and Internal and external audits.
- BS Degree in scientific discipline: Engineering or related science.
Certified Quality Engineering (CQE) preferred.
- A minimum of 5 years of experience working within a quality function and experience working in an FDA or ISO regulated environment.
- Understanding of continuous improvement strategies including Lean, Six Sigma and validation.
- Excellent people interaction, team building, and communication skills.
For more information please don't hesitate to call Aoife on 086 044 3981 and I would be happy to discuss the role with you in more detail.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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