Design Assurance Quality Engineer

Matrix Recruitment

Westmeath, Roscommon, Galway

What you need to know. You will work as a Design Assurance Quality Engineer for our client, a highly successful and well-established medical manufacturing company in Co. Galway . As the Design Assurance Quality 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. You will report to the Quality Manager/Senior Design Assurance Engineer. This is a permanent job. Your new job. Key duties & responsibilities: 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. What are we looking for? 3rd Level Degree in Scientific or Technical discipline. At least 3+ years Design Assurance / Quality Engineering in the pharmaceutical or Medical Device sector. 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. Apply for this job now or get in touch with Michéal on 090 6490485. By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and consent. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given. We Value Your Trust. This job originally appeared on RecruitIreland.com.

2054 days ago