Principal Quality Engineer

• 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.

Job Scope

Provide technical analysis of processes that are involved in the development of products and the manufacturing of products in order to ensure that products developed and manufactured are consistent and meet specifications. Help and support such activities while ensuring that applicable standards and procedures are followed. Mentor and train junior level Quality Engineers. Participate in Project teams and representing Quality/Regulatory groups and ensure that Design Control requirements are met. Support Corrective and Preventive actions and ensure that Root Cause Investigations are performed using appropriate Quality Tools. Support Manufacturing processes and ensure that validation activities are well documented and performed.

Key Duties and Responsibilities

• Ensure that appropriate procedures are established to support Design Development and the Manufacturing processes.
• Review design and development processes and ensure that appropriate documentation is established during this process and in accordance with the Design Control procedures.
• Review manufacturing and validation activities to ensure that they are well established and compliant with the regulations.
• Establish purchasing controls and work very closely with suppliers of critical components and sub systems.
• Work with suppliers of critical components, sub systems and finished products to ensure that all changes are appropriately validated at the supplier and evaluated for impact to DiaSorin Molecular's product.
• Gather, analyze, and report data reflecting status of product and process and provide recommendations to improve such activities.
• Ensure that software lifecycle and validation requirements are met and are compliant with the regulations including software developed for DiaSorin Molecular or as part of our assay equipment.
• Review specifications, manufacturing instructions, process procedures, test procedures, inspection and test analysis.
• Provide leadership in the application of Quality Tools such as Risk Management, Root Cause Investigations, Designs of Experiments, Capability Studies, in the establishment and investigation of process and products failures and implement lasting solutions of such failures.
• Develop process flow diagrams and perform gap analyses on current controls versus required controls.
• Establish methods to analyze and investigate the root cause of external and internal non-conforming products.
• Assist in corrective and preventive actions and verifications of effectiveness checks.
• Analyze data from customer complaints, internal audits, and internal and external supplier's non-conformance and implement appropriate solutions.
• Develop inspection procedures and apply statistical techniques and appropriate sample plans.
• Participate in improvement and Lean projects.
• Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
• Participate in Audits (Internal and External), and Regulatory authority inspections and ensure that risk to company is minimized as much as possible.
• May oversee daily responsibilities of lower-level Quality Engineers or Quality Associates.
• Perform other duties as assigned.

Education, Experience, and Qualifications

• Bachelor's Degree preferred in an Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bioengineering, or Quality Engineering
• Minimum of 10 years related experience in IVD, medical, pharmaceutical, or other related industry.
• Thorough understanding of statistical analysis and statistical process control
• Knowledge of Investigation and Root Cause Analysis, Corrective and Preventive Action Process, and their application to development and manufacturing processes as a problem identification and resolution tool
• Thorough understanding and experience in software lifecycle and validation requirements.
• Proficient in Quality Analysis Tools (Taguchi, Fishbone) & DOE
• Thorough understanding of all aspects of the DMAIC model in accordance with Six Sigma principle.
• Basic knowledge of Lean enterprise concepts; are able to identify non-value-added elements and activities.
• FDA Product and Process Validation Techniques
• Solid experience in Systems Development including Hardware (Instrumentation), Software and Consumable/Reagents
• 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 top management, public groups, managers, clients, and customers.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• ASQ Certified Quality Engineer a plus, but not required.
• Certified Quality or Biomedical Auditor a plus, but not required.
• Six Sigma Black Belt a plus, but not required.

What we offer

• Receive a competitive salary of $135K - $145K annually 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.