|Job Title:||Design Assurance Engineer|
Our Client is seeking to hire a Design Assurance Engineer to provide technical support to Design Engineers, Project Managers and Clients throughout product development processes.
The ideal candidate will be coming from a background in Medical Devices and have a minimum of 3 years of experience working in Product Design and R&D. This role reports to the Engineering Manager. It is a Full time, Permanent position.
- 3rd Level Qualification in Engineering or Science discipline
- Minimum 3 years in Medical device Environment and knowledge of cGMP.
- Experience in Validation (Process, Packaging, sterilization) would be a distinct advantage.
- Excellent communication skills, written and verbal, and the ability to communicate with the team, managers and clients in a clear and appropriate manner.
- Strong numerical and problem-solving ability.
- Knowledge of MDR & FDA Product submission requirements.
- Strong knowledge of ISO 13485, FDA Regulations 21CFR820
Duties and Responsibilities
- Working closely with clients and the product development engineering team to complete designs and products that are compliant with FDA regulations
- Performing quality reviews of process validation plans, design verification protocols and reports.
- Constant reviewing of production SOPs, work instructions and material specifications to ensure compliance with cGMP procedures.
- Keep accurate and up to date files at all stages of product development
- Coordinate product design reviews and complete associated documentation.
- Support Quality Department in implementing and maintaining QMS
- Provide support for audit preparation
- Other duties as required by management