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 meets specifications. Help and support such activities while ensuring that applicable standards and procedures are followed. Mentor and train junior level Quality Engineers.
Manage the NCMR system - review issues, recommend CAPA, review investigation reports, monitor efficacy, and close NCRs in a timing fashion.
Ensure that appropriate procedures are established to support Design Development and the Manufacturing processes.
Review of design and development processes and ensuring that appropriate documentations are 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 closely with suppliers of critical components and sub systems.
Work with suppliers of critical components, sub systems and finished product 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.
Qualifications Experience Personal Strengths Mobility
Engineering or life sciences discipline such as Mechanical, Electrical, Industrial, Manufacturing Engineering, Bio-Engineering, or Quality Engineering.
Minimum of 10 years related experience in IVD, medical, pharmaceutical, or other related industry.
Must have a thorough understanding and experience in NCMR (Nonconforming Material Report) system
Proficient in Quality Analysis Tools (Taguchi, Fishbone) & DOE.
Must have a thorough understanding of all aspects of the DMAIC model in accordance with Six Sigma principles. They have 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.
Previous mentoring of quality personnel desired.
Must have a thorough understanding and experience in NCMR (Nonconforming Material Report) system.
Must have a thorough understanding of statistical analysis, statistical process control, 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.
Must have a thorough understanding and experience in software lifecycle and validation requirements.