Quality Engineer

About the Company

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.

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.

About the Role

As a member of the Product Quality Assurance Engineering team, this role will serve as a subject matter expert and go-to authority regarding best Quality practices. You will ensure all Product Quality-related activities are performed in compliance with business objectives and act as an internal consultant on Process Controls, Equipment and Process Validation, Nonconforming Product, Risk Management, new Product Development, CAPA, Design/Change Control, and Statistical Methods.

Responsibilities

• Provide QA representation, support, and advisement within cross-functional teams relating to:
  • Non-conforming product
  • CAPA
  • Process and Material Validation
  • Change Management
  • Design Control and new Product Development
  • Supplier quality and manufacturing issues
  • Corporate and local quality plans/projects
  • Continual improvement of the QMS and product quality
  • Operational Excellence and Lean projects
  • Risk Management
• Support the NCR (Non-Conformance) system – review and approve issues, make recommendations, monitor efficacy through key NCR process metrics, and drive success.
• Ensure procedures are established and accurate to support new Product Development, Product Design Transfer, and manufacturing processes.
• Review design and development processes to ensure appropriate documentation aligns with Design Control procedures.
• Review manufacturing and product development validation activities to ensure they are well-established, risk-based, and compliant with applicable regulations.
• Review, approve, and provide recommendations on Change Requests.
• Gather, analyze, and report data reflecting the status of product and process, and provide recommendations for improvement.
• Use statistical tools to analyze data for acceptance decisions and process/product improvement.
• Review and approve equipment and process validation protocols/reports.
• Recommend methods, techniques, and principles to ensure compliance, safety, efficacy, and efficiency.
• Work with manufacturing and supply chain to resolve supply issues of critical components, subsystems, and finished products, ensuring all changes are appropriately validated.
• Initiate, investigate, own, drive, and/or participate in NC and CAPA issues as needed.
• Analyze and translate technical data.
• Participate on the internal audit team and support external audits.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree in Engineering, Life Sciences, or related field, or equivalent experience.
• 3+ years of quality engineer experience in medical device or other regulated industry.
• Knowledge of FDA QSR and ISO 13485, 9001 & 14971, and MDSAP Compliance.
• Experience with CAPA and Root Cause Analysis.
• Quality Auditing (performing internal audits and participating in external audits).
• Document and Change Control.
• Nonconformance Process.
• Design and New Product Development.
• Process Validation methodology.
• Risk Management and usage of PFMEA templates.
• Statistical methods (process capability, hypothesis testing, regression/correlation, SPC, DOE).
• Computer skills and software knowledge – MS Word, PPT, and Excel.
• Knowledge of Immunochemistry/immunoassay.
• Six Sigma methodology.
• IVDR or MDR.
• Software Validation and Data Integrity.
• Working knowledge of statistical methods.
• Usage of a QMS software system.

Pay

The hiring range for this position is $74,800 - $93,400 annually. The salary range reflects numerous factors considered in hiring decisions, including education, skills, work experience, and certifications.

Benefits

Beyond base salary, Diasorin offers a competitive rewards package focused on overall well-being, including:

• A comprehensive plan of health benefits.
• Retirement and financial well-being programs.
• Time off programs.
• Wellbeing support and perks.
• Eligibility to participate in an annual incentive program (award depends on individual and organizational performance).