Supplier Quality Engineer

Stevanato Group; Fishers (IN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Daily meal stipend

100% employer paid Dental benefits

100% employer paid Vision benefits

3 weeks of PTO

10 paid holidays

8 sick days

Job summary

A manufacturing company in Fishers, IN is seeking a Supplier Quality Engineer responsible for ensuring supplier compliance with quality standards and regulatory requirements. The role involves collaborating with cross-functional teams, conducting audits, and managing quality issues related to suppliers. Candidates should have 4-7 years of experience in Supplier Quality within the medical field, alongside a Bachelor's degree. This position offers a chance for growth in a state-of-the-art facility with comprehensive benefits, including paid holidays and PTO.

Qualifications

• Minimum 4-7+ years’ experience in Supplier Quality, preferably in pharma or medical devices.
• Knowledge of applicable standards: ISO, cGMP, FDA, etc.
• Experience with supplier selection and qualification processes.

Responsibilities

• Deploy systematic processes for supplier qualification.
• Serve as a contact for quality issues with suppliers.
• Coordinate and perform supplier audits.

Skills

Supplier Quality Management

Collaboration with cross-functional teams

Root cause analysis

Continuous improvement

Education

Bachelor's Degree

Tools

ISO standards

cGMP

FDA regulations

PPAP

Job description

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.

Key Responsibilities

• 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.

Requirements

• 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

Why work with us?

• 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