Senior QA Specialist: Regulatory Compliance & Audits

Asuragen, Inc.; Austin (TX); On-site; USD 56,000 - 91,000; Full time

Benefits offered by this job

Competitive benefits from day one

401k + ESPP

Job summary

Bio-Techne, through its Asuragen brand, seeks an Advanced Quality Assurance Specialist to advance the Quality Management System in alignment with ISO 13485, FDA QSR, MDSAP and IVDR requirements, ensuring product quality and compliance.

You will collaborate with project teams, perform internal and external audits, manage document control, CAPA, NCRs and supplier quality, and help train staff while maintaining metrics for Quality Management Reviews.

Qualifications

• Bachelor's or Master's degree in a related field.
• 4-6 years of experience in a regulated manufacturing facility or equivalent.
• Experience implementing ISO 13485, FDA QSR, and related regulatory standards.

Responsibilities

• Ensures compliance with regulatory standards, systems, procedures, and practices.
• Supports internal and external audits and summarizes results for Quality Management.
• Manages Document Control, Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management.

Skills

QA principles

ISO 13485

FDA QSR

MDSAP

cGMP

Audits

Data analysis

Documentation

Training

Regulatory compliance

Education

Bachelor's or Master's degree in related field

Tools

Microsoft Office

Database management

Job description

Bio-Techne, through its Asuragen brand, seeks an Advanced Quality Assurance Specialist to advance the Quality Management System in alignment with ISO 13485, FDA QSR, MDSAP and IVDR requirements, ensuring product quality and compliance.

You will collaborate with project teams, perform internal and external audits, manage document control, CAPA, NCRs and supplier quality, and help train staff while maintaining metrics for Quality Management Reviews.