Supplier Quality Engineer

Stevanato is hiring a Supplier Quality Engineer to join our growing plant in Fishers, IN!

The Supplier Quality Engineer is responsible for executing activities related to the qualification and certification of suppliers, ensuring their compliance with product and process regulatory requirements, quality standards, and customer expectations. This role supports the achievement of high-quality service delivery by effectively implementing the Quality Management System, contributing to cross-functional processes, and providing expertise in supplier quality management.

• Deploy robust, systematic processes for supplier qualification and certification.
• Serve as a single point of contact for quality issues related to suppliers.
• Collaborate with Supply Chain, Operations, and Commercial teams to provide technical feedback and reports.
• Execute quality specifications for materials, products, and services supplied.
• Participate in new product launches and validate supplier capabilities.
• Monitor supplier process changes and apply methodologies like PPAP.
• Conduct root cause analyses to resolve quality issues.
• Develop procedures and questionnaires for supplier qualification and certification.
• Support Procurement in supplier selection, assessing process capabilities and risk.
• Coordinate and perform supplier audits to evaluate service quality and compliance.
• Follow up on audit actions and the status of supplier certification.
• Analyze complaint trends, product quality data, and supplier performance.
• Propose and implement continuous improvement actions and KPIs.
• Maintain a supplier repository and related documentation.
• Ensure a consistent approach to supplier issues, aligned with QMS standards.

• Minimum 4-7+ years’ experience in Supplier Quality, preferably within the pharmaceutical or medical device industry
• Bachelor's Degree
• Previous experiencer working directly with suppliers.
• Knowledge of applicable standards: ISO, cGMP, FDA, CFRs, PMDA, ANVISA, COFEPRIS, REACH, etc.
• Experience with supplier Selection and Qualification processes
• CAPA, Change Control, PPAP, and Auditing techniques

• Brand new facility located in the Fishers Life Sciences and Innovation Park
• Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend
• 100% employer paid Dental and Vision benefits
• Modern space with brand new technology, climate-controlled production floor
• Opportunity for growth, development, and advancement
• 3 weeks of PTO, 10 paid holidays, 8 sick days