Director, Quality Assurance

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Director, Quality Assurance

Published on:
Dec 16, 2025

Country:
United States

Company:
Luminex Corporation

Job Category:
Quality

Employment type:

Regular Full Time

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin? Impactful Work:
When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. Global Reach &

Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. Diverse and Inclusive Culture:
We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. Join Our Team:
If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare.

Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

The Quality Assurance Director is responsible for leading and maintaining the Quality Management System (QMS) for the Dia Sorin Molecular business unit, ensuring full compliance with all applicable regulatory requirements, including but not limited to FDA, ISO 13485, IVDD/IVDR, CMD/CAS, and relevant federal, state, and local regulations. This individual serves as the designated Management Representative and provides strategic oversight of the QMS with a focus on Operational Quality, ensuring its effective implementation and continuous improvement in alignment with both local and international regulatory expectations.

Key Duties and Responsibilities

• Quality System Oversight:
  • Manage and continuously improve the QMS to align with lean manufacturing principles, ensuring it supports product quality, operational efficiency, and regulatory compliance. Lead cross-functional quality initiatives that drive measurable improvements in compliance, productivity, and risk mitigation.
• Regulatory Compliance:
  • Serve as the primary point of contact for regulatory inspections and audits. Maintain up-to-date knowledge of applicable regulations and ensure organizational practices remain compliant. Lead efforts to identify and address compliance gaps proactively.
• Manufacturing Quality & Process Excellence:
  • Provide expert-level technical analysis of product development and manufacturing processes to ensure conformance to specifications and quality standards. Leverage root cause analysis, statistical methods, and lean tools (e.g., FMEA, 5 Whys, value stream mapping) to drive process improvements and reduce non-conformances.
• Mentor and develop junior Quality Engineers, fostering a culture of quality, accountability, and continuous improvement. Champion training initiatives to enhance technical competencies and regulatory knowledge across the Quality team.
• Actively participate in cross-functional project teams, representing Quality functions for the Chicago site. Ensure compliance with Design Control requirements throughout the product lifecycle, from concept through commercialization.
• Lead and support the execution of Corrective and Preventive Actions (CAPA), ensuring root cause investigations are thorough and utilize appropriate quality tools. Promote a data-driven approach to risk identification, analysis, and mitigation in both development and manufacturing environments.
• Validation & Documentation:
  • Oversee validation planning and execution for manufacturing processes, equipment, and software. Ensure all validation activities are appropriately documented in compliance with internal procedures and external regulatory requirements.
  • Act as Management Representative and IVDR Person Responsible for Regulatory Compliance (PRRC) for the site. In this capacity, ensure that product meets label claims and customer satisfaction, any quality or regulatory issue is elevated to the Dia…