Director, Quality Assurance — Austin Medical Devices

DiaSorin; Austin (TX); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Time off programs

Wellbeing support

Annual incentive program

Job summary

Diasorin is seeking a Director, Quality Assurance for the Austin site to lead and improve quality systems, ensure regulatory compliance, and mentor teams across functions. You will oversee audits, CAPA, investigations, and continuous improvement in a fast-paced diagnostics environment.

This role requires a strong background in cGMP, ISO standards, and cross-functional leadership to drive quality initiatives and ensure patient safety and product reliability.

Qualifications

• Bachelor degree in science or engineering with 8+ years in QA or regulatory roles.
• 10+ years in quality assurance or regulatory activities in a cGMP Medical Device or Pharmaceutical environment.
• Knowledge of ISO 13485, ISO 14971, CFR 820 and CFR 806 and international regulations.
• 2+ years of management experience in a complex quality assurance/quality systems field.
• Excellent problem solving methodology and analytical skills.
• Strong interpersonal, verbal and written communication skills.

Responsibilities

• Ensure that the Austin site demonstrates regulatory compliance per GLP/GCP/cGMP/GXP, ISO, and other applicable regulations.
• Lead QA strategy for manufacturing and service depot of instruments for customers and partners in compliance with regulations.
• Identify opportunities for continual improvements in product/service quality, customer satisfaction, and profitability.
• Manage external audits (ISO, FDA or other regulators) for the Austin site and coordinate responses.
• Oversee CAPA, investigations, risk assessments, and change control in the QA system.
• Collaborate with Site Leadership and Field Quality to manage customer complaints and nonconformances.

Skills

Leadership

Regulatory compliance

Quality systems

Auditing

Risk management

Problem solving

Cross-functional

Continuous improvement

Education

Bachelor degree in science or engineering

Job description

Diasorin is seeking a Director, Quality Assurance for the Austin site to lead and improve quality systems, ensure regulatory compliance, and mentor teams across functions. You will oversee audits, CAPA, investigations, and continuous improvement in a fast-paced diagnostics environment.

This role requires a strong background in cGMP, ISO standards, and cross-functional leadership to drive quality initiatives and ensure patient safety and product reliability.