Description
Senior Supplier Quality Engineer (Medical Devices) - 6 Months - Ireland - €40/€45 per hourA Global Medical Device company is searching for a Supplier Quality Engineer to help them with a bottle neck of work over the coming months. The company manufacture a variety of Medical Devices, ranging from low to high risk and previous Medical experience is necessary.
Ideal applicants would have Class III experience, but any lack of this can be compensated by extensive client side experience. The position is due to start 1st April, but this could be pushed a week either side if the availability of a suitable applicant doesn't align.
If you would like to organsie a call to discuss this position in more detail, please email Robert Marrett () to organise a call.
Tasks
- Perform key deliverables in support of development and continuous engineering R&D projects, which include: mould tool qualifications, component qualifications, design and product risk assessments, and shelf life validations.
- Provide quality engineering support to manufacturing lines, including floor support, non-conforming product investigations, documentation change request reviews, and new equipment qualifications, and be a factory-focus team member.
- Perform return product investigations for product complaints.
- Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines.
- Work with manufacturing and R&D engineers to prepare manufacturing work instructions, material specifications, and inspection documentation for new products. Set inspection requirements, set inspection methods and inspection sampling plans.
- Support quality control inspectors with new product inspections and quality issues that arise during inspections.
- Support and test component changes to current products.
- Support internal audits and supplier audits.
Requirements
- S. degree in Engineering or related field
- 3-5 years in an engineering role.
- Working experience of GMP and ISO 13485 requirements highly preferred.
- Strong written and oral communication skills.
- Working knowledge and understanding of mechanical drawings.
- Strong problem solving, technical writing, and statistical analysis skills.