QA Engineer- IVD Diagnostics and Process Excellence

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 have 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."

• Impactful Work:
  When you join Diasorin, you become part of a team that is 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!

Responsible for evaluating and optimizing manufacturing, and CAPA processes to improve product consistency, ensure regulatory compliance, and increase productivity. Responsible for end-to-end validation life cycles for new and existing products while applying strong business acumen to balance quality requirements with operational efficiency. Supports all applicable regulations including but not limited to FDA, ISO
13485.

• Review of design, manufacturing, purchasing, and test documentation to ensure quality requirements are fulfilled.
• Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.
• Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test).
• Assist in determining process/equipment capabilities.
• Assist in the development of process flow diagrams and perform gap analyses on current controls versus required controls.
• Investigate the root cause of external and internal non-conforming products.
• Drive corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits, and internal and external suppliers non-conformance.
• Perform assessments of process-related risks, bridging the gap between technical quality requirements and business goals to support strategic decision-making.
• Assist in the development of inspection procedures and justified sample plans.
• Develop and maintain systems to collect, analyze, and report data reflecting status of product and process and provide recommendation to improve.
• Represent quality on new product development teams for design transfer with guidance from more senior quality engineers or management.
• Apply project management principles to lead continuous improvement and Lean initiatives.
• Perform other duties as assigned.

• Education:
  
  Bachelor s Degree and/or equivalent experience in a Life Sciences discipline (Biochemistry, Chemistry, Microbiology, etc.) or Engineering discipline (Mechanical, Electrical or Industrial Engineering).
• Experience:
  • 2+ Years related experience in IVD, medical, pharmaceutical, or other related industry.
  • Proven experience in Process, Product, and/or Method Validation is required.

• ASQ Certified Quality Engineer preferred.

• Must have a thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool.
• Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE.
• FDA Process Validation Techniques preferred.
• 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 managers, clients,…