Director Quality Assurance

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

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters
  Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture
  Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

The Director, Quality Assurance for Austin will lead, establish, implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for commercial medical devices designed, produced and marketed by Luminex. Partner with Manufacturing, Design/Development, Systems Engineering, Quality Control and others across functions to deliver the highest quality instruments, and reagents. This position is responsible for the oversight, control and release of instruments and reagents, quality organizational management, budget preparation, personnel management, organizational goals and metrics, and Executive Level presentations. The Director, Quality Assurance for Austin is a leader and a mentor.

Key Responsibilities and Duties

• Ensures that the Austin site demonstrates regulatory compliance per GLP/GCP/cGMP/GXP, ISO, and other applicable regulations.
• Support instrument new product development and manufacturing changes, provides guidance to the core teams and participate in the process.
• Leader in process optimization by Identifying and analyzing opportunities for continual improvements in product/service quality, customer satisfaction, and company profitability.
• Leads the strategy and improvements for the manufacturing and service depotof Instruments for our customers and partners in compliance with regulations and standards.
• Participates and manage activities for external audits such as ISO, FDA or other regulatory bodies for the Austin site. Acts in Audits - as co-host, SME or escort
• Responds to alleged QMS violations of regulations, policies, procedures as the result of both external and external audits by evaluating and recommending the initiation of investigative activities, immediate corrections and risk analysis processes. Coordinates responses to external audits and manages corrective actions to close.
• Interacts with various internal and external groups to facilitate the completion of internal audits, handling of non-conformances, performing Risk Assessments, CAPA, investigation and support, manufacturing validation as well as Design Transfer.
• QMS improvements and enhancements and is a leading member of the Quality Management Team. Works across the corporation to align and define quality approach for molecular diagnostic products.
• Partners with Site Leadership and Field Quality to conduct, manage, and evaluate investigations related to customer complaints, nonconformances, audits, corrective/preventive action concerns, deviations, recalls, and potential injuries
• Appropriately escalated Quality issues to the Vice President Quality Assurance Molecular Division
• Provide leadership in the application of Quality Tools such as Risk Management, Root Cause Investigations, Designs of Experiments, Capability Studies, in the establishment and investigation of process and products failures and implement lasting solutions of such failures.
• May act as IVDR Person Responsible for Regulatory Compliance (PRRC) for Luminex sites to ensure: the conformity of the devices is appropriately checked before a device is released, the post-market surveillance and reporting obligations are fulfilled and all requirements established between Luminex and Authorized representative are met.
• May act as Management Representative for the site. In this capacity, ensure that product meets label claims and customer satisfaction, any quality or regulatory issue is elevated to the President and/or Vice President Quality Assurance Compliance North America and oversee and drive continuous improvement.
• Develops and releases Change Plans and actions to support the changing needs and requirements of the organization as the result of strategic changes in business direction
• Provide other Quality related technical training as necessary
• Directs activities of employees or through managers who exercise full supervision for daily operations. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Maintains talent through recruiting and development opportunities. Continually develops internal candidates through succession planning and career development.
• Responsible for enforcing all EHS policies in their span of control
• Be part of any the new key and strategic projects and due diligence process if required
• Ensure all site-level activities and related documentation are aligned with corporate procedures and conducted in accordance with DiaSorin's established Corporate and Quality Assurance governance requirements.

Education, Experience and Qualifications

• Minimum Bachelor degree in a science or engineering discipline with 8+ years of relevant experience/training
• 10+ Years of Experience in Quality Assurance or Regulatory Affairs activities in a cGMP Medical Device or Pharmaceutical environment
• 5+ years of Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971, CFR 820 and CFR 806 and international regulations preferred
• 2+ years of Management experience in a complex quality assurance/quality systems field
• 2+ years of Ability to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
• 5+ years of Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.
• 5+ years of Hands-on ability to sort through technical complexities and work in a flexible changing environment.
• 5+ years of Possesses a strong scientific and technical background, sufficient to establish creditability with senior management as well as the manufacturing and product development teams.
• Excellent interpersonal, verbal and written communication skills
• Thorough knowledge of standards and regulations (cGMP, ISO 13485)
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• High degree of problem solving, attention to detail, and analytical skills.
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Ability to handle the pressure of meeting tight deadlines

What We Offer

Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].

Nearest Major Market: Austin

Country: United States

Location: Austin, Texas

Company: Luminex Corporation

Job Category: Quality

Employment type: Regular Full Time