Senior QA Leader for Life Sciences & Diagnostics

Asuragen, Inc.; Austin (TX); On-site; USD 78,000 - 129,000; Full time

Benefits offered by this job

Competitive benefits on day one

401(k) plan and ESPP

Tuition reimbursement and development

Job summary

Bio-Techne is seeking a Senior Quality Assurance Specialist to enhance the Quality Management System in line with global standards. You will collaborate with internal teams to ensure product quality, lead audits, and drive continuous improvement across QA processes.

The role emphasizes regulatory knowledge, training delivery, and cross-functional leadership within a regulated manufacturing environment.

Qualifications

• Bachelor’s or Master’s degree in a related field with relevant regulated manufacturing experience.
• 7–10 years (Bachelor) or 4–6 years (Master) in a regulated facility is expected.
• Strong knowledge of QA, ISO 13485, FDA QMSR, MDSAP and related standards.

Responsibilities

• Lead compliance with regulatory standards, systems, procedures and practices.
• Oversee QA production reviews, approvals and product releases.
• Represent QA in new product design and development teams.
• Lead external audits and communicate results to QA management.
• Manage Document Control, Training and production QA activities.
• Direct NCR, CAPA, Complaints, Internal Audits and Supplier Management systems.
• Review and approve validation activities and equipment maintenance records.

Skills

QA principles and concepts

Auditing & regulatory compliance

Documentation control

Training & CAPA management

Statistical tools usage

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in a related field

Master's degree in a related field

Tools

Microsoft Office

Database management

Job description

Bio-Techne is seeking a Senior Quality Assurance Specialist to enhance the Quality Management System in line with global standards. You will collaborate with internal teams to ensure product quality, lead audits, and drive continuous improvement across QA processes.

The role emphasizes regulatory knowledge, training delivery, and cross-functional leadership within a regulated manufacturing environment.