Are you a Senior Quality Engineer with experience in an NPI environment looking for new and exciting projects? If so, then read on because we have the opportunity for you!
You will join us in a newly created role supporting the team with a focus on New Product Introduction (NPI) and concept programmes. As our new Senior Quality Engineer (NPI) You role will be to define and monitor all aspects of NPI.
In this role you will get the opportunity to work with all levels of the business, customers, suppliers and regulated bodies, using your skills and knowledge to influence deliverable dates for the completion of activates that ensure that we meet our customer requirements.
Using customer specifications you will review and releasing NPI product for clinical trials, validation, and verification testing while identifying any risks that could have an impact on product compliance. You will write and approve documents required for technical files, protocol and reports which may include MDF/DHF, human factors and 10993 testing.
A key part of this role will be to identify and implement continuous improvement through the lifecycle management of the product(s). This is a great opportunity for someone who is looking to utilise their Quality Engineering skills within a manufacturing environment working on concept and NPI programmes which could include combination products and point of care devices.
To be successful in this role we’re looking for you to have the following skills, experience and knowledge:
• Educated to degree level (or equivalent)
• Proven experience in a similar role with in a Quality or NPI environment.
• Good working knowledge of ISO 13485, 21 CRF Part 820, ISO 14971, ISO 10993, GMP (Orange Guide) European MDR, QSIT.
• Passionate & results focused through a strong teamwork approach
Permanent, Full Time
Additional Salary Info
- Industry Sector Engineering, Utilities