Quality Assurance Director

DiaSorin; Northbrook (IL); On-site; USD 151,000 - 216,000; Full time

Job summary

DiaSorin is seeking a Quality Assurance Director responsible for leading the Quality Management System for its Molecular business unit. This role requires expertise in regulatory compliance, process improvement, and managing audits to ensure product quality and operational efficiency. Join a company dedicated to innovation in diagnostics and make a significant impact in healthcare through quality assurance.

Benefits

Comprehensive health benefits plan

Retirement and financial well-being support

Annual incentive program eligibility

Generous time off programs

Qualifications

• Minimum 7+ years in medical device management.
• 5+ years in quality management experience required.
• Preferred certifications: ASQ Certified Quality Engineer.

Responsibilities

• Lead and improve the Quality Management System (QMS).
• Ensure compliance with federal and international regulations.
• Manage audits and regulatory inspections.

Skills

Regulatory Compliance

Quality Management System

Process Improvement

Audit Management

Education

Bachelor's Degree in Engineering or Life Sciences

Master’s Degree in Engineering or Life Sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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 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.

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, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at [e-mail] or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.