Supplier Quality Engineer

You will be responsible for liaising with suppliers and drive quality improvements as well as being both the voice of the customer and voice of the supplier to ensure favourable outcomes for the business. Other activities will include: 

• To manage and drive continuous/ process improvement activities and defect reduction initiatives.
• To process Nonconformity, Planned Deviations and Supplier Activities.
• To conduct CAPA investigations.
• To act as QA representative for product and process change requests and validation protocols.
• To perform product release activities.
• To provide support for new product introduction.
• To actively promote a Quality Culture.

In addition, you will also be responsible for:

• To liaise with suppliers and drive quality improvements.
• Ensure critical data are collected, analysed and acted upon when necessary, identification of trends and actions to correct ensuring these are driven through to completion
• Establish and maintain effective working relationships across the whole business and supply chain
• Identification of, and participant in, Continuous Improvement (CI) projects
• Lead and ensure effective closure of Supplier Corrective Action Forms.
• Review and update of key supply chain / supplier related documentation as and when changes to business needs occur (such as customer requirements)
• Lead effective supplier process and management system audits.
• Supporting new product and process development projects.
• Supporting the implementation of continuous improvement initiatives.
• Supplier evaluation/approval/performance monitoring.
• Be a point of contact in supplier audits, as well as conducting internal and external audits.
• Non-conformity investigation, reporting and trending.
• CAPA investigation, reporting and trending.
• Change Control review.
• Product release.
• Environmental Monitoring.
• Tracking/trending results from Goods Receiving Inspection, In-process and Batch Control activities.
• Management of ad hoc investigatory projects.

Competencies for the Role:

1. Familiar with using databases and business management systems (ERP/eQMS).
2. Competent in IT practices and use of Microsoft applications.
3. Possess the ability to investigate and solve complex issues and define root cause using good analytical skills.
4. Strong communicator with excellent oral and written presentation skills.
5. Possess the ability to work alone and as part of multi-disciplinary teams.
6. Good people management skills

Skills & Experience Required:

Essential:

• Proven track record of Process Improvements resulting in Cost/Efficiency/Time improvements within a manufacturing environment.
• Degree, equivalent qualification or equivalent experience in a science, clinical or engineering background.
• 2-3 years’ experience in a Quality Engineering role.
• Experience with Quality System concepts, practices and procedures (e.g. ISO:13485, CFR820).

Desirable:

• Working knowledge of cGMP, FDA 21 CFR Part 820 QSR and ISO 13485 Medical Device Quality Management Systems