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Company

Quest Diagnostics · 5 hours ago

Principal Software Quality Engineer (Remote)

Secaucus, NJ

Full-time

Remote

Lead/Staff

8+ years exp

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BiotechnologyHealth Care

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Responsibilities

This position is responsible for leading Quality Assurance and software regulatory activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of product development and Quality Systems.

This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices including supporting the Cyber security development processes and Cyber Bill of Materials

This role will interface with other cross-functional teams (e.g. Research and Development, Enterprise IT Dev Ops, Operations, Bioinformatics, Clinical Services, Diagnostics services, Laboratory Operations, Manufacturing, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, software used for automation of the IVD products, and Quality management systems

Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity

Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) and ssPMA Submission

Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements

Plan for the Verification and Validation of the system requirements and user needs for the integrated system

Support team through the process of gathering customer needs from different stakeholders, translate them into system design, system requirements, and sub-system requirements that form the basis of system validation ensure sub-systems maintain performance when integrated

Support development teams on the validation of software development tools

Provide guidance for the generation, review and approval of design control documentation with primary focus on software development deliverables

Collaborate with research and development and automation to support the Design Control process and Continuous Improvement initiatives to optimize our SW Development processes

Serve as the Software Design Control expert to various Medical Device development projects across the organization

Develop and deliver Design Control training for the software development, Bioinformatics, IT, Research and development, and other functions

Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation

Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback

Support the creation of necessary documentation to comply with regulatory requirements and industry best practices

Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304

Own the Risk Analysis process to meet ISO 14791 requirements, including Hazard Analysis, FMEA, management and tracing of risk controls, and planning and tracing of verification and validation of risks

Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304

Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management

Drive and continuously improve our Quality Management System Regulation (QMSR) to ensure all design and development activity is fully compliant with global medical device regulations and standards.

Qualification

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Software Quality EngineeringHazard AnalysisFMEAMedical device software developmentRisk managementDesign Control SystemsFDA 21 CFR Part 820ISO 13485IEC 62304ISO 14971IEC 62366IEC 60601Atlassian JIRAAtlassian ConfluenceGitLabElectronic Quality Management SystemsSoftware validation practicesCQE certificationSix Sigma Black BeltSix Sigma Green Belt

Required

BS degree, in an engineering/scientific/computer system/ or quality management curriculum or equivalent experience.

A minimum of 8-10 years’ work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.

Experience with Hazard Analysis (HA), and Failure Mode and Effect Analysis (FMEA)

Experience with medical device software development.

Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools.

Experience with software mobile applications, cloud-based systems, and cybersecurity.

Experience in the development and implementation of effective Design Control Systems.

Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.

Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for ssPMAs, and 510(k).

Bachelor’s Degree(Required)

Quality Engineer (CQE)

Six Sigma Certified Black Belt

Six Sigma Certified Green Belt