QA Engineer

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  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.
  

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  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

Responsible for evaluating and optimizing manufacturing, QC, and CAPA processes to improve productconsistency and to increase productivity. Responsible for reviewing, performing, and documenting validations fornew and existing products. Supports all applicable regulations including but not limited to FDA, ISO, andCMD/CAS requirements.

Responsibilities and Duties

• 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.
• Assist in 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 for process-related risks.
• Assist in the development of inspection procedures and justified sample plans.
• Gather, 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.
• Participate in improvement and lean projects.
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree in an engineering discipline (Mechanical, Electrical or Industrial Engineering) or life sciences discipline (Biochemistry, Chemistry, Microbiology, etc.)
• 2+ Years related experience in IVD, medical, pharmaceutical, or other related industry and
• Software product development experience within the IVD environment

Licenses and Certifications

• ASQ Certified Quality Engineer

Training and Skills

• 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, customers, and the general public.
• 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.