TalenTier · 14 hours ago
Quality Specialist
TalenTier is seeking a detail-oriented and proactive Quality Specialist to join their Quality Department in Austin, TX. The role involves supporting and managing quality processes including CAPAs, SCARs, and NCMRs while ensuring compliance with internal procedures and regulatory standards.
Staffing & Recruiting
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related field
0–2 years of experience in a Quality or Regulatory environment
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
Preferred
Familiarity with CAPA, SCAR, NCMR, and Quality KPI processes
Experience with OBIEE and Agile PLM
Company
TalenTier
At TalenTier, we're passionate about connecting amazing people with amazing companies.
Funding
Current Stage
Early StageCompany data provided by crunchbase