Senior Quality Assurance & Compliance Specialist (ISO 9001)

Catapult; Charlotte (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

HSA with employer contribution

10 company-paid holidays

15 days vacation

Job summary

The QA Specialist role is an onsite position based in Charlotte, North Carolina. You will support and maintain the Quality Management System (QMS) in alignment with ISO 9001, cGMP, UL and FSC programs, ensuring regulatory compliance and a strong quality culture across SATO America.

Responsibilities include non-conformance management, audits, supplier quality oversight, document control, and continuous improvement initiatives, with 25-50% travel as needed.

Qualifications

• 3-5 years' proven experience in Quality Assurance or Regulatory Compliance in manufacturing.
• Internal auditor certified (CIA/CQA) and ISO 9001 knowledge.
• Experience with non-conformance investigations and CAPA management.
• MS Office proficiency including Excel, PowerPoint, and Visio.

Responsibilities

• Non-Conformance Management: manage deviations, CAPAs, and quality events per ISO 9001.
• Regulatory & Compliance: support regulatory requests and audits; ensure inspection readiness.
• cGMP Compliance Auditor: conduct audits and recommend corrective actions.
• Internal Auditor: plan and execute internal audits across departments.
• Supplier Quality Audits: perform supplier qualifications and audits as needed.
• Customer Feedback: respond to inquiries, complaints and corrective actions.
• Document Control: manage SOPs, work instructions, and quality records.
• Quality Training: support and deliver quality training and maintain records.
• Cross-Functional Engagement: attend QA meetings; support change management risk assessments.
• Problem-Solving & RCA: lead root cause analysis and sustainability actions.
• Inspections: perform inspections and related testing as needed.
• Safety (EHS): comply with EHS policies and participate in audits and safety actions.
• Safety Culture & Quality Culture: promote prevention, accountability and continuous improvement.

Skills

MS Office

Excel

PowerPoint

Visio

Education

High School Diploma or GED

College degree or equivalent

Tools

MS Office

Job description

The QA Specialist role is an onsite position based in Charlotte, North Carolina. You will support and maintain the Quality Management System (QMS) in alignment with ISO 9001, cGMP, UL and FSC programs, ensuring regulatory compliance and a strong quality culture across SATO America.

Responsibilities include non-conformance management, audits, supplier quality oversight, document control, and continuous improvement initiatives, with 25-50% travel as needed.