Supplier Quality Engineer

Cytiva - Marlborough, MA

Full-time - Mid Level

Marlborough, MA

Chemical Manufacturing

About the position

The Supplier Quality Engineer for Cytiva is responsible for managing site level as well as CMO suppliers and the associated Quality Management System records, issuing and supporting the closure of Supplier Corrective Actions (SCARs), conducting audits and qualifying suppliers, and managing change requests from suppliers. This position is part of Supplier Quality located in Duncan, SC and will be onsite. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.

Responsibilities

• Primary areas of focus will be supplier qualification, part/process qualification, supplier auditing, issue resolution and improving supplier quality performance through continuous improvement activities and quality plan implementation.
• Effectively problem solve with the skills to lead Root Cause investigations / CAPA plans and ability to influence others cross-functionally.
• Collaborate with Suppliers and internal Stakeholders to drive Quality improvements that minimize the Costs of Quality and support implementation of Supplier/Engineering Changes, New Product Introductions and Transfers.
• Develop and execute Corrective and Preventive Action plans with suppliers to resolve non-conformance issues.
• Up to 20% travel to suppliers may be required.

Requirements

• Bachelor's degree in Engineering or technical field.
• 3-5 years of experience in manufacturing, engineering or quality assurance, or quality engineering preferably in the biotech or pharmaceutical industries.
• Excellent communicator and collaborator who can influence at all levels of the organization.
• Experience in supplier technical development or supplier quality development.
• Qualified auditor experience preferably in both on-site and remote/virtual environments.
• Knowledge of quality critical aspects in industrial process control and how to verify and validate them through process qualification.

Nice-to-haves

• Experience in Kaizen events, process improvement/ value stream mapping.
• Experience in CMO relationships.