Advanced Quality Assurance Specialist
Bio-Techne · Austin, TX
QualityFull-time$56k–$91kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Advanced Quality Assurance Specialist supporting regulatory compliance and quality management systems at a life sciences tools company. Role involves audits, document control, training, and quality system oversight across ISO, FDA, and international standards.
What they're looking for
- Bachelor's or Master's degree in related field from accredited institution
- 4-6 years experience in regulated manufacturing facility or equivalent combination
- Proficiency with Microsoft Office and database management software
- Knowledge of cGMP, ISO 13485, MDSAP, IVDR, and FDA QSR
- Strong written and oral communication skills
- Analytical and problem-solving abilities with independent work capability
- Familiarity with statistical tools in regulated environments
What you'll be doing
- Ensure compliance with regulatory standards including ISO 13485, FDA QSR, MDSAP, and IVDR
- Conduct internal and external audits with results analysis and reporting
- Manage or support document control, training, NCR, CAPA, complaints, and supplier systems
- Review and approve validation activities and quality equipment calibrations
- Support regulatory and client audits and generate quality metrics
Privacy & handoff
This role links to Bio-Techne's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.