Supplier Quality Engineer

Fantastic opportunity to join a global manufacturer of innovative market leading medical devices, an organisation that have been at the forefront of the coronavirus pandemic and continue to grow their teams at a rapid rate.

This position provides support to the Global Supplier Quality organization dedicated to the oversight of Chem/Bio/Packaging components/subassemblies. He/she will provide technical knowledge across the organization to ensure suppliers can meet all requirements.

• Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management.
• Coordinate and execute activities related to the implementation of new raw material suppliers because of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that the suppliers comply with the requirements stipulated in the quality system before the closure of the projects.
• Conduct technical reviews on raw material suppliers to understand their capability to make parts/raw materials.
• Update the ERP system with the status of the approved suppliers for the different raw materials.
• Train in the respective procedures in the training system, before executing the respective task.
• Maintain supplier performance metrics to be used in decision making. Provide the necessary reports to other departments as required.

• Working knowledge of ISO 13485 and 21 CFR part 820
• QMS/ISO 9001 or 13485 Lead Auditor Training / Internal Auditor Training
• Full Clean Driving licence.
• 3-5+ years’ experience in IVD or medical device manufacturing or related industry
• Demonstrated practical approach towards decision making and problem resolution.
• Good understanding of supplier quality.
• Knowledge of continuous improvement techniques.
• Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation.
• Must be able to work independently and communicate with all levels of the organisation.
• Computer literate - knowledge of Word, PowerPoint and Excel an advantage - to produce reports, analyse data etc. effectively.