Job Title: Supplier Quality Engineer
Location: Cramlington, UK
Part of the BioProduction (BPD) Division the team in Cramlington produce our range of Single-Use Technologies (SUT) which are typically used by biopharma companies around the world for drug development. We produce more than 2,000 products for our growing customer base and have been producing these products at Cramlington since 1997.
We have an exciting opportunity for a Supplier Quality Engineer on a 12 month fixed term contract to interface with suppliers and supply chain to drive quality improvements. You will develop positive relationships and work closely with Purchasing departments to ensure that suppliers meet quality expectations. Being used to working in a fast-paced environment you will accelerate improvements in supplier quality and drive supplier selection through robust qualification processes.
Location/Division Specific Information:
- Approve and monitor supplier corrective action plans and activities to closure to ensure that root cause is identified and appropriate action is taken.
- Conduct audits of supplier quality systems acting as lead auditor.
- Perform activities that will qualify new suppliers and work with product development teams to ensure that supplier related aspects are addressed.
- Manage Supplier change notifications and Quality Agreements.
- Manage assigned Process Owner/QA owner responsibilities in Trackwise.
- Assist with Quality approvals for Master Control documents and specifications.
- Conduct internal audits, quality walks and provide support for on site Customer audits.
- Analyse data to drive process improvements.
Preferred education & experience:
- Degree in an Engineering or Scientific based subject and several years of supplier quality experience within the Pharmaceutical\\Biotech Industry.
Key skills & abilities:
- Qualified Lead Auditor preferred but previous experience in internal/external auditing may be substituted.
- Strong working knowledge of Current Good Manufacturing Practices (cGMPs) & ISO 9001 & 13485.
- Ability to understand various manufacturing processes including those involving plastics, chemicals and or biologics
- Exceptional report writing skills.
- Strong communication skills with the ability to interface well with others at all levels, including Customers & Suppliers.
- Ability to develop and implement procedures.
- Extensive knowledge and understanding of continuous improvement with exceptional problem solving skills.
- Must be computer literate with knowledge of Microsoft Office.
- Ability and willingness to undertake training as part of his / her own role & to train others where required.
- Meticulous attention to detail, ability to work to strict deadlines and to work calmly, whilst under pressure.
- Must be self-assertive and able to drive new initiatives within the remit of their role.
- Availability and ability to work overtime at short notice.
- Travel will be required (domestic and some foreign).
- To perform any other duties as may be reasonably 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.