Job Details for Senior Design Quality Engineer
What you need to know
You will work as a Senior Design Quality Engineer and will work for our Medical client based in Co. Galway.
You will be responsible for the compliance of existing products both internally and externally. You will be part of a team who will review product requirements. You will be responsible for providing quality engineering support to Engineering projects.
This is a temporary position with excellent opportunities for career progression within a large organisation.
Your new job
Key duties & responsibilities
- You will aid in the operation of design controls as well as product design changes for quality purposes i.e. testability, reliability and manufacturability.
- You will be responsible for the compliance of existing products both internally and externally (e.g. FDA, ISO). You will be part of a team who will review product requirements.
- You will provide support in the formation of validation test plans.
- You will overlook analysis and testing for product requirements and will provide for statistical analysis of validation test results using statistical tools i.e. Minitab.
- You will display familiarity with significant industry standards g. IEC60601 series, particularly 60601-1-2, 60601-1-8, and 60601-2-12.
- Manage the product development projects internally with clients in line with ISO 130485 and FDA 21CFR 820.30 guidelines.
- Report and document on the performance of projects.
- Organise project design review agenda and facilitate effective project reviews.
- Comply with internal and external regulatory requirements.
- Ensure documentation such as product development, manufacturing process and test specifications/procedures are completed.
- Undertake process development activities.
What are we looking for?
- Bachelor’s degree (Level 7 NFQ) in a relevant technical discipline Engineering/Science.
- Minimum 5 years relevant experience.
- Charismatic team player who can work productively with the Engineering team.
- Experience in a manufacturing environment ideally with experience in the medical device sector.
- Possess and demonstrate strong leadership skills.
- Strong project management experience.
- Excellent analytical and problem-solving skills.
- Excellent knowledge of design for manufacturing of injection tools and assembly processes.
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.