Location: Austin, TX

Pay: $25hr

Job Title/High-Level Position Summary:

We are seeking a detail-oriented and proactive Quality Specialist to join our Quality Department in Austin, TX. This fast-paced role is ideal for someone passionate about quality systems, metrics, and continuous improvement. You will play a key role in supporting and managing quality processes including Field Actions, CAPAs, SCARs, and NCMRs, ensuring full compliance with internal procedures and regulatory standards.

Reporting directly to the QMS Manager, this position is responsible for maintaining and reporting critical quality metrics that reflect the overall health of plant operations and production/quality controls. These metrics are regularly shared with senior leadership and cross-functional teams to drive performance, accountability, and compliance across the organization.

Key Responsibilities:

• Support the initiation, investigation, and closure of:
• Corrective and Preventive Actions (CAPA)
• Supplier Corrective Action Requests (SCAR)
• Non-Conformance Reports (NCMR)
• Trends in Quality Metrics and Key Performance Indicators (KPIs)
• Maintain accurate and timely documentation within the Quality Management System (QMS).
• Collaborate with cross-functional teams to gather data and ensure timely resolution of quality issues.
• Monitor and report the status of open quality records.
• Assist in root cause analysis and effectiveness verification for CAPAs and SCARs.
• Ensure compliance with company policies, procedures, and applicable regulations (FDA, ISO 13485, etc).
• Participate in internal audits and support external audits as needed.
• Identify trends, recurring issues, and opportunities for process improvement.

Minimum Basic Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 0–2 years of experience in a Quality or Regulatory environment.
• Familiarity with CAPA, SCAR, NCMR, and Quality KPI processes are preferred.
• Strong attention to detail, organization, and analytical skills is a must.
• Excellent written and verbal communication abilities.
• Ability to work independently and collaboratively in a cross-functional team environment.
• Proficiency in Microsoft Excel; experience with OBIEE and Agile PLM preferred.

Travel Requirements:

• 0-25%