Senior QA Lead: Regulatory Compliance & Quality Systems

Bio-Techne; Austin (TX); On-site; USD 78,000 - 129,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k plan

Employee stock purchase plan

Job summary

Bio-Techne is seeking a Senior Quality Assurance Specialist to join the Quality Assurance team in Austin, TX. The role focuses on maintaining and improving the Quality Management System in line with international standards, with direct involvement in product release and audits.

The position requires leadership in QA activities, strong knowledge of regulatory frameworks, and ability to collaborate with cross-functional teams to drive continuous quality improvements.

Qualifications

• Bachelor’s or Master’s degree with relevant regulated manufacturing experience.
• Experience with ISO 13485, FDA QMSR, MDSAP, IVDR is preferred.
• Ability to lead audits and reviews of processes.

Responsibilities

• Lead regulatory compliance efforts across QA systems and practices (ISO 13485, FDA QMSR, MDSAP, IVDR).
• Execute QA production reviews, approvals and product release.
• Act as QA lead in design and development teams.
• Lead external audits and summarize results for QA management.
• Manage Document Control, Training and QA production related activities.
• Oversee Training, CAPA, NCR, Complaints, Internal Audits and supplier quality systems.

Skills

QA principles

Statistical tools

Excellent communication

Detail oriented

Cross-functional teamwork

Auditing

Education

Bachelor's degree in a related field

Master's degree in a related field

Job description

Bio-Techne is seeking a Senior Quality Assurance Specialist to join the Quality Assurance team in Austin, TX. The role focuses on maintaining and improving the Quality Management System in line with international standards, with direct involvement in product release and audits.

The position requires leadership in QA activities, strong knowledge of regulatory frameworks, and ability to collaborate with cross-functional teams to drive continuous quality improvements.