Job Details for Design Assurance Quality Engineer
What you need to know
Matrix Recruitment is working closely with our client in the Healthcare Sector in Co. Galway in the recruitment of a Design Assurance Quality Engineer.
This is a permanent position and you will be reporting to the Quality Manager/Senior Design Assurance Engineer.
You will contribute to the support of activities relevant to the design and development of new products. You will lead and participate in product development to ensure its approval for distribution.
Your new job
- You will interact with Process Development, Clinical, Marketing and Research & Development to aid in the provision of new product designs.
- Assist with the implementation of compliance to the Quality Management program.
- Prepare and approve design assurance specifications and assist in the generation of written policies and procedures.
- Participate in the development, validation and implementation of the manufacturing processes.
- Develop product risk assessment documentation (design FMEA’s).
- Generate essential data to support new product proposals.
- Ensure all areas comply with laid down regulatory requirements.
- Create device labelling and advertising materials.
- Produce design plans and reports for new products in line with procedures. compliant.
What are we looking for?
- Degree in Scientific or Technical discipline.
- Minimum 3 years Design Assurance / Quality Engineering in the Pharmaceutical or Medical Device sector.
- 5 years experience in a managed setting, ideally medical device, FDA or ISO 13485 registered work environments.
- Knowledge and understanding of product development process and design control requirements i.e. risk assessment, FMEA’s, and test method development
- Detailed understanding and knowledge of FDA, European, Japanese and other regulatory requirements .
- Strong communication skills and strong teamwork capabilities.
- Exceptional problem solving and analytical skills and proficient at multitasking.
Apply for this job now or get in touch with Marguerite on 09064 90485.
Matrix Recruitment Group is committed to providing a professional service where all CV’s are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent.