Job Title: Quality Engineer
Location: Cramlington, UK
As Quality Engineer you will work closley with the Operations group and provide technical support to ensure products and processes meet the required quality standards. You will lead investigations for both customer complaints and internal process/product failures and drive the implementation of appropriate corrective and preventation actions. Develop relationships with Customers and the Commercial Team by providing technical support on and off Site.
Other Duties Include:
- Manage assigned Process Owner/QA owner responsibilities in Trackwise
- Assist with Quality approvals for Master Control documents and specifications
- Priovide assistance with routine validations & custom testing
- Conduct internal audits, quality walks and provide support for on site Customer audits
- Analyse data to drive process improvements.
Preferred Education & Experience:
Degree in a Scientific or Engineering based subject and extensive experience within the Pharmaceutical\\Biotech or Engineering Industry.
- Sound working knowledge of Current Good Manufacturing Practices (cGMPs) & applicable ISO standards (ISO9001/ISO13485)
- Strong technical knowledge of manufacturing processes
- Extensive knowledge and understanding of continuous improvement with exceptional problem solving skills.
- Strong communication skills with the ability to interface well with others at all levels, including Customers & Suppliers.
- Qualified ISO Auditor
- Detailed knowledge of Validation processes.
- Exceptional report writing skills
- Computer literate with sound knowledge of Microsoft Office
- Meticulous attention to detail, ability to work to strict deadlines and to work calmly, whilst under pressure.
- Must be self-motivated and able to drive new initiatives within the remit of their role.
- Ability and willingness to undertake training as part of his / her own role & to train others where required.
- To understand and accept personal responsibilities for Health & Safety on site in compliance with UK legislation and the Company’s Health & Safety Management System.
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