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Diasorin · 6 hours ago

Quality Engineer

Cypress, CA

Full-time

Onsite

Mid Level

Diasorin is a global leader in diagnostic solutions, committed to improving healthcare worldwide. The Quality Engineer will be responsible for evaluating and optimizing processes to enhance product consistency and productivity, ensuring compliance with relevant regulations while supporting new product development.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

Responsibilities

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 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

Support new product development and growth. Represent quality on new product development teams with guidance from more senior quality engineers or management

Participate in improvement and lean projects

Performs internal audits

Responsible for performing assigned tasks in accordance with the company’s quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual

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

Qualification

Quality ControlProcess ValidationRegulatory ComplianceFMEARoot Cause AnalysisData AnalysisTeam CollaborationProblem Solving

Required

Responsible for evaluating and optimizing manufacturing, QC, R&D and CAPA processes to improve product consistency and to increase productivity

Responsible for reviewing, performing, and documenting validations for new and existing products

Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and IVDR requirements

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 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

Support new product development and growth

Represent quality on new product development teams with guidance from more senior quality engineers or management

Participate in improvement and lean projects

Performs internal audits

Responsible for performing assigned tasks in accordance with the company's quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual

Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies

Perform other duties as assigned

Company

Diasorin

Glassdoor3.1

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics

Founded in 1968

Saluggia, Piemonte, ITA

1001-5000 employees

https://www.diasorin.com/

H1B Sponsorship

Diasorin has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)