£ 50000.00 per annum
We specialise in the design, development and manufacture of complex medical devices for the world's leading pharmaceutical companies at low, medium and high-volume manufacturing scales. We are focused on continual product innovation for drug delivery devices production and have been dedicated to world-class design, industrialisation and reliable high-volume supply for over 50 years.
Due to continued growth we have a newly created role for a Senior Quality Engineer. The role will support the team with a focus on New Product Introduction (NPI) and concept programmes. Working with our Head of Quality Systems and a team of up to 5 direct reports you will 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 are looking for you to have the following skills, experience, and knowledge:
- Educated to degree level (or equivalent)
- Proven experience in a similar role within 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
You will have the room to use your passion and self-motivation to make positive influence on business-critical projects.
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