Senior Quality Assurance Specialist

Senior Quality Assurance Specialist at Bio-Techne will lead quality system compliance, regulatory standards management, and continuous improvement initiatives for a diagnostics manufacturer. The role involves oversight of audits, validation, training, and cross-functional project leadership within a regulated manufacturing environment.

Responsibilities

• Ensure compliance with ISO 13485, FDA QMSR, MDSAP, IVDR and other regulatory standards
• Lead quality system management including training, NCR, CAPA, complaints, and supplier oversight
• Execute production reviews, approvals, and product release decisions
• Conduct and summarize external audits; identify and communicate risks to management
• Review and approve validation activities and equipment calibration records

Requirements

• Bachelor's degree in related field with 7-10 years regulated manufacturing experience
• Master's degree in related field with 4-6 years regulated manufacturing experience
• Proficiency with Microsoft Office and database management software
• Knowledge of ISO 13485, FDA QMSR, cGMP, and MDSAP regulatory frameworks
• Ability to lead audits, manage compliance systems, and train staff effectively
• Strong analytical and problem-solving skills with independent work capability
• Excellent written and verbal communication with cross-functional collaboration skills

Compensation: $78,100-$128,500