Supplier Quality Specialist

Supplier Quality Specialist

The Supplier Quality Specialist is responsible for ensuring that suppliers consistently deliver materials, components, and services that meet company quality standards, regulatory requirements, and customer expectations. This role works closely with suppliers, procurement, manufacturing, engineering, and quality teams to drive continuous improvement and resolve quality issues.

Key Responsibilities

• Evaluate and qualify new suppliers through audits, assessments, and performance reviews.
• Monitor supplier quality performance using key metrics reported.
• Investigate supplier-related quality issues and lead root cause analysis activities.
• Review and approve supplier corrective and preventive action plans (CAPA) utilizing the Supplier Notification and SCAR programs.
• Collaborate with purchasing and engineering teams during supplier selection and development processes.
• Analyze quality data and prepare reports on supplier performance trends.
• Ensure compliance with applicable standards, regulations, and customer requirements.
• Support new product introductions by validating supplier processes and capabilities.
• Drive continuous improvement initiatives to reduce defects, improve quality, and lower costs.
• Maintain supplier quality documentation, records, and audit reports.
• Participate in audits to ensure compliance with quality management systems and industry standards (in collaboration with the North American Teams).

Basic Qualifications

• High School Diploma and preferred cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience in a required.
• Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
• Proficient in MS Office programs, including Word and Excel.
• Ability to process information rapidly from multiple sources and communication channels.
• Ability to handle a high volume of work and rapidly adapt to changing environment.

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you'll find plenty of chances to grow both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.