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 innovate in the lifescience arena and grow their teams in a time of economic uncertainty.

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.