Quality Assurance Director

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  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.
  

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  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.
  

Job Scope

The Quality Assurance Director is responsible for leading and maintaining the Quality Management System (QMS) for the DiaSorin 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.
  
  
  
  
• Training & Leadership:
  
  
  
  • 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.
  
  
  
  
• Project Participation:
  
  
  
  • 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.
  
  
  
  
• CAPA & Risk Management:
  
  
  
  • 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 DiaSorin Molecular President and/or DiaSorin S.p.A Head of Corporate Quality/Regulatory, and oversee and drive continuous improvement of the Quality Systems.
  
  
  
  
• Among additional duties, the main responsibilities are as detailed in Article 15 of the EU IVDR 2017/746:
• Perform other duties as assigned.

Education, Experience, and Qualifications

• Bachelor's Degree or relevant field required. Examples could be Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bioengineering, and/or Quality Engineering.
• Master's degree or relevant field preferred. Examples could be Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bioengineering, and/or Quality Engineering.
• Minimum 7+ Yearsmanagement experience in medical device industry, IVD experience
• 5+ Years experience to include at least five years of experience in quality management.
• Specific Licenses and Certifications Preferred: ASQ Certified Quality Engineer, Lean Six Sigma Black Belt, Certified Quality or Biomedical Auditor a plus, but not required.

Training and Skills

• Thorough knowledge of International, Federal, State, FDA regulations and ISO 13485 Quality Management Systems is required.
• Must have a thorough understanding and experience in software lifecycle and validation requirements.
• FDA Product and Process Validation Techniques.
• Must be proficient in Microsoft Word, Microsoft Excel and Microsoft PowerPoint.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of top management, public groups, managers, clients, and customers.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

What we offer

The salary range for this position is $151,200 - $216,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, etc. Beyond base salary, 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 well-being, time off programs, well-being 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.