Capa Engineer Jobs in Minnesota (NOW HIRING)

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.

• 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

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 and ensuring all Product Quality related activities are performed in a complaint manner to support business objectives. In addition, as a member of the Product Quality Assurance Engineering team, this role will be responsible for serving as an internal consultant on the following activities: Process Controls, Equipment and Process Validation, Nonconforming Product, Risk Management, new Product Development, CAPA, Design/Change Control and Statistical Methods.

Job Responsibilities and Duties

• Provide QA representation, support and advisement within cross-functional teams relating to (but not limited 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 help to support and drive the success of metrics
  Ensure procedures are established and accurate to support new Product Development, Product Design Transfer and manufacturing process
  Review design and development processes, ensuring appropriate documentation is established in accordance with the Design Control procedures
  Review manufacturing and product development validation activities to ensure that 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 status of product and process and provide recommendations to improve such activities
  Use statistical tools to analyze data to make acceptance decisions and improve processes and product
  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, sub systems and finished product to ensure that 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 internal audit team and support external audits
  Perform other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree in Engineering, Life Sciences or related field, or equivalent experience required or

• 3+ Years years of quality engineer experience in medical device or other regulated industry
  FDA QSR and ISO 13485, 9001 & 14971 and MDSAP Compliance
  CAPA and Root Cause Analysis
  Quality Auditing (both in 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
  Immunochemistry/immunoassay
  Six Sigma methodology
  IVDR or MDR
  Software Validation and Data Integrity
  Working knowledge of statistical methods
  Usage of a QMS software system
  required

What we offer

The hiring range for this position is $74,800 - $93,400 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 hr@diasorin.com.

Recruitment Fraud Notice

Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact hr@diasorin.com for verification.

Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.