About Sovrin Medical Plastics
We are an ISO 13485 certified contract manufacturer, supplying Precision Injection Mouldings, Assemblies and Medical Devices to the Pharmaceutical, Drug Delivery and Healthcare industries.
Job Description
As a Quality Engineer at Sovrin Medical Plastics, you will have the opportunity to work closely with customers and all other departments on new projects, from conception through validation and into production.
Your key tasks will include:
* Liaising with customers as the primary contact for quality-related correspondence.
* Driving validation through IQ/OQ/PQ as part of NPI project teams.
* Establishing metrology methods using modern contact and non-contact CMMs to validate and monitor precision components.
* Maintaining the QMS and acting as the quality lead through aspects including CAPA, RCA, change control, document control, risk assessments and audits.
* Generating reports from capability studies to Validation Summary Reports.
* Writing Work Instructions and SOPs and implementing training to personnel.
* Providing guidance and support in GMP/GDP/DI throughout the company.
Requirements
The successful candidate will have:
* Experience working in injection moulding/engineering/medical device manufacturing.
* A comprehensive understanding of ISO13485:2016.
* The ability to read and interpret complex engineering drawings.
* The capability to operate and program Mitutoyo contact and non-contact CMMs.
* The confidence to interact professionally with others at all levels internally and externally.
* Proficiency in MS Office (Excel, Word, PowerPoint, Outlook).
Benefits
We offer a negotiable remuneration package commensurate with your skills/abilities and experience, up to £50,000.00 per year. The position is full-time, permanent with an 8 hour day shift, Monday to Friday and potential overtime.
We require a minimum of 3 years quality assurance experience and work authorisation in the United Kingdom.