Job Description

• As part of a team of Supplier Quality Engineers, lead Quality activities within the supply chain teams.
• Maintain the approved suppliers list and individual supplier files in an audit ready state for regulatory body and customer review.
• Process requests for new suppliers and complete all risk/evaluation activities required to add new suppliers.
• Maintenance of Quality agreements with key suppliers.
• Coordinate, direct and manage supplier quality activities with focus on issue resolution (SCAR reports), supplier approval, supplier development, process control, and quality assurance.
• Drive continuous improvement in the supply chain process.
• Develop/maintain relationships with key suppliers.
• Schedule, plan and perform global supplier audits for TA Glasgow, Terumo collaborative audit team – to an approved audit schedule.
• Support internal audit schedule as required.
• Control and maintenance of first article inspection process activities for high risk suppliers.

Development Responsibilities;

• Engage in the development of improved and new products and provide project support adding technical strength to product development.
• Adopt a work ethic that promotes good customer service.
• From time to time it may be necessary to undertake other business-related activities that can be reasonably expected of them, for the benefit of the company.
• Work in a manner that promotes the company`s values.

Required Knowledge, Skills, and Abilities

Relevant Science/Technical Degree or equivalent industry experience. Proven Supplier Quality experience. Manufacturing experience in a Medical Device Environment preferred, equivalent experience from a different regulated industry will be acceptable. Knowledge of regulatory standards, Quality Management Systems & global regulations for medical devices desired (understanding of key requirements of ISO 13485, FDA 21 CFR Part 820, MDR and MDSAP). Lead Auditor qualification/experience required. Flexibility to travel globally to fulfil requirements of the SQE role. Demonstrable analytical & problem-solving skills. Excellent facilitation, coordination, prioritization, presentation and communication skills.