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Diasorin · 1 day ago

Director, Quality Assurance

Northbrook, IL

Full-time

Onsite

Director/Executive

$151K/yr - $216K/yr

7+ years exp

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. 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 and providing strategic oversight of the QMS with a focus on Operational Quality.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

Hiring Manager

Samantha Howard

Responsibilities

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

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

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

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

Perform other duties as assigned

Qualification

Quality Management SystemRegulatory ComplianceLean Six SigmaFDA RegulationsSoftware ValidationStatistical AnalysisProject ManagementLeadershipCommunicationTeam CollaborationProblem Solving

Required

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

Minimum 7+ Years management experience in medical device industry, IVD experience

5+ Years experience to include at least five years of experience in quality management

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

Preferred

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

Specific Licenses and Certifications Preferred: ASQ Certified Quality Engineer, Lean Six Sigma Black Belt, Certified Quality or Biomedical Auditor a plus, but not required

Benefits

Comprehensive plan of health benefits

Retirement and financial well-being

Time off programs

Well-being support and perks

Annual incentive program

Company

Diasorin

Glassdoor3.1

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics

Founded in 1968

Saluggia, Piemonte, ITA

1001-5000 employees

https://www.diasorin.com/

H1B Sponsorship

Diasorin has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (1)

2022 (1)