Senior Director, Quality Assurance - Medical Devices (Austin)

DiaSorin S.p.A.; Texas; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Time off programs

Wellbeing support

Annual incentive program

Job summary

Luminex Corporation in Austin, Texas is seeking a Director, Quality Assurance to lead and refine quality systems for our medical devices. You will oversee regulatory compliance, risk management, CAPA, internal audits, and cross-functional engagement to ensure product quality and patient safety.

This role requires 8+ years in QA or regulatory affairs in cGMP environments, strong leadership, and a track record of improving processes across manufacturing, development, and QC.

Qualifications

• 8+ years of experience in Quality Assurance or Regulatory Affairs in a cGMP Medical Device or Pharmaceutical environment.
• Experience leading QA teams and implementing regulatory workflows.
• Strong knowledge of ISO 13485, FDA QSR and related standards.
• Proven ability to manage internal and external audits and CAPA programs.
• Excellent communication and leadership skills in cross-functional teams.

Responsibilities

• Lead and maintain QA systems ensuring compliance with regulatory standards.
• Oversee investigations, CAPA, change control and risk management activities.
• Coordinate internal and external audits (ISO, FDA, etc.).
• Partner with Manufacturing, Design/Development, and Quality Control to drive continuous improvement.
• Provide leadership and mentoring to QA staff and site leadership.

Skills

QA leadership

Regulatory compliance

GXP knowledge

Auditing

Risk management

Education

Bachelor's degree in science/engineering

Job description

Luminex Corporation in Austin, Texas is seeking a Director, Quality Assurance to lead and refine quality systems for our medical devices. You will oversee regulatory compliance, risk management, CAPA, internal audits, and cross-functional engagement to ensure product quality and patient safety.

This role requires 8+ years in QA or regulatory affairs in cGMP environments, strong leadership, and a track record of improving processes across manufacturing, development, and QC.