Quality Assurance Specialist

DiaSorin; Minnesota; On-site; USD 68,000 - 83,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Time off programs

Wellbeing support

Annual incentive program

Job summary

Diasorin in the United States seeks a Quality Assurance Specialist to support the Quality Management System, ensuring compliance with procedures and regulatory requirements. The role spans document control, audits, CAPA, and cross-functional quality activities.

Join a global diagnostics leader focused on innovation, patient care, and a strong culture of accountability. The position offers a competitive salary with benefits and opportunities for professional growth.

Qualifications

• Bachelor's Degree in engineering, life sciences or related field required.
• Master's Degree preferred.
• 3+ years in related field or demonstrated competence within a cGMP environment required.
• Experience using Microsoft Office (MS Word, Excel, PowerPoint) required.
• Familiarity with ISO 13485, 21CFR820 and IVDR desirable.

Responsibilities

• Support the administration, maintenance, and continuous improvement of the Quality Management System to ensure compliance with applicable procedures, standards, and regulatory requirements.
• Review Quality records and documentation for completeness, accuracy, compliance, and adherence to established requirements.
• Partner with cross-functional teams to implement and maintain Quality System processes and promote consistent application of quality and compliance requirements.
• Lead or participate in Quality System improvement initiatives, implementation activities, special projects, and cross-functional programs.

Skills

Quality mindset

Analytical thinking

Regulatory knowledge

Document control

Team collaboration

Education

Bachelor's Degree in engineering, life sciences or related field

Master's Degree preferred

Tools

SmartSolve

SAP

Microsoft Office

Job description

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Quality Assurance Specialist

Country: United States

Job Category: Quality

Employment type: Regular Full Time

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 Quality Assurance Specialist supports the administration, execution, maintenance, and continuous improvement of the Quality Management System to ensure compliance with applicable procedures, standards, and regulatory requirements. The role may support multiple Quality System processes based on business needs, experience, and assigned areas of responsibility, and works cross-functionally to promote effective, compliant, and sustainable Quality processes.

Job Responsibilities

• Support the administration, maintenance, and continuous improvement of the Quality Management System to ensure compliance with applicable procedures, standards, and regulatory requirements.
• Perform assigned Quality System activities, which may include document and records management, change management, product or batch record review and release, training administration, electronic Quality Management System administration, calibration, supplier qualification/re-qualification, issuing and managing supplier corrective actions (SCAR), planning and performing internal/supplier audits and other QMS processes.
• Review Quality records and documentation for completeness, accuracy, compliance, and adherence to established requirements; identify and facilitate resolution of issues as appropriate.
• Partner with cross-functional teams to implement and maintain Quality System processes and promote consistent application of quality and compliance requirements.
• Support qualification, monitoring, maintenance, and periodic review activities associated with assigned Quality System processes, systems, suppliers, equipment, or records.
• Generate, analyze, monitor, and communicate Quality System data, metrics, trends, and other information used to evaluate QMS performance and identify opportunities for improvement.
• Provide guidance and training to employees on Quality System requirements, procedures, systems, and good documentation practices.
• Support internal, external, corporate, customer, notified body, and regulatory audits and inspections, including preparation and follow-up activities.
• Participate in or support investigations, nonconformances, CAPA, risk assessments, and other Quality processes requiring Quality Systems expertise.
• Administer or support electronic systems used to manage Quality processes, records, training, or compliance activities.
• Lead or participate in Quality System improvement initiatives, implementation activities, special projects, and cross-functional or cross-site programs.
• Support other Quality System activities, including post-market, vigilance, audit, and compliance activities, based on business needs, individual experience, and assigned responsibilities.
• Maintain applicable Quality records and ensure activities are performed in accordance with established data integrity and documentation requirements.
• Perform other functions as required.

Education, Experience and Qualifications

• Bachelor's Degree in engineering, life sciences or related field required
• Master's Degree preferred
• 3+ Years in related field or demonstrated competence within a cGMP corporate environment required
• Experience using Microsoft Office (MS Word, Excel, PowerPoint) required
• Service oriented mentality and a strong focus on customer needs
• Strong independent / cross-disciplinary skills
• Ability to work independently with minimal supervision as well as with a team
• Ability to work in a regulated environment
• Ability to train team members on basic group procedures and tasks
• Effective process management and analytical skills
• Experience in the following areas:
  • Quality System Standards and Regulations such as ISO 13485, 21CFR820 and IVDR
  • cGMP
  • Document and Change Control
  • Quality Auditing
  • CAPA
  • Nonconformance Process
  • Complaint / vigilance processes
  • Problem-solving skills
  • Ability to analyze trend data
  • High degree of initiative, good judgement and decision-making skills
  • Computer skills and software knowledge
  • Proficiency in Microsoft Office applications
  • Familiarity with SmartSolve or other eQMS software, SAP or other enterprise software is desirable

Travel Requirements

• 10% Travel to supplier sites for auditing purposes

What we offer

The hiring range for this position is $67,500 - $82,500 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, 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 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] .