Quality Engineer I

at  DiaSorin

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!

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.
  Qualifications

Bachelor’s or Master’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
• 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

What we offer
Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
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 hrtalent@diasorin.com 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

Please refer the Job description for details