Supplier Quality Specialist

Fagron Nederland BV; Wichita (KS); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical, vision and dental

Health Savings Account (HSA)

Holiday/paid time off

Job summary

Fagron is seeking a Supplier Quality Specialist in the U.S. to ensure suppliers deliver materials that meet quality and regulatory standards. You will collaborate with procurement, manufacturing, engineering and QA to drive improvements and resolve quality issues.

Responsibilities include supplier audits, CAPA reviews, data analysis and cross-functional support for new product introductions. Strong cGMP knowledge and MS Office proficiency are essential for success.

Qualifications

• High School Diploma required; cGMP experience preferred.
• Experience with quality systems, CAPA, change control and root cause analysis preferred.
• Proficiency with MS Office, especially Word and Excel.
• Ability to review cGMP documentation and quality investigations.
• Experience in audits and supplier quality programs is a plus.

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.
• Review and approve CAPA plans and supplier SCAR actions.
• Collaborate with purchasing and engineering during supplier selection and development.
• Analyze quality data and prepare supplier performance reports.
• Ensure compliance with standards, regulations and customer requirements.
• Support new product introductions by validating supplier processes.
• Drive continuous improvement to reduce defects and costs.
• Maintain supplier quality documentation and audit reports.
• Participate in audits with North American teams for compliance.

Skills

Quality systems

Aseptic technique

cGMP documentation

CAPA

Change Control

MasterControl

MS Office

Data analysis

Audit proficiency

Education

High School Diploma

Tools

MasterControl

MS Office (Word, Excel)

Job description

About The Job

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.

What's on Offer?

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.

Ready For The Challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.