Supplier Quality Specialist

Job Description

Day to Day: The Supplier Quality Specialist is responsible for supporting the supplier quality program through the review and management of supplier audit reports, Supplier Corrective Action Requests (SCARs), and quality system documentation. This individual will ensure audit findings are accurately documented, corrective actions are appropriately implemented and verified, and supplier quality records are maintained in compliance with regulatory and corporate quality standards. The role requires strong knowledge of audit methodologies, CAPA principles, supplier quality management, and electronic Quality Management Systems (eQMS).

Supplier Corrective Action Request (SCAR) Management

• Manage and track approximately 400 Supplier Corrective Action Requests (SCARs) annually.
• Review supplier responses to audit findings and SCARs for adequacy and completeness.
• Evaluate containment actions, corrections, root cause investigations, corrective actions, and preventive actions submitted by suppliers.

CAPA Review & Compliance

• Apply CAPA methodology and quality system principles to evaluate supplier responses.
• Assess root cause analyses for thoroughness and effectiveness.
• Review verification of implementation and verification of effectiveness plans.
• Ensure corrective actions adequately address underlying causes of supplier nonconformances.
• Monitor CAPA progress and escalate overdue or ineffective corrective actions.

Audit Program Support

• Support audit planning activities, including development of audit agendas and audit criteria.
• Ensure audit findings are properly documented and incorporated into quality system workflows.
• Facilitate transition of audit findings into formal SCAR processes when required.

Skills and Requirements

• 3+ years of experience in Supplier Quality, Quality Assurance, Compliance, or Quality Systems.
• Working knowledge of supplier audits, CAPA systems, and supplier corrective action processes.
• Experience reviewing audit reports and evaluating regulatory or quality system non-conformances.
• Strong understanding of root cause analysis and corrective/preventive action methodologies.
• Experience using electronic Quality Management Systems (eQMS) such as Arena, Agile, MasterControl, Veeva, TrackWise, or equivalent.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].