Software Quality Engineer

Global Technical Talent; Secaucus (NJ); Remote; USD 180,000 - 220,000; Full time

Job summary

A leading company in diagnostic information services is seeking a Software Quality Engineer. This role involves ensuring compliance with regulatory standards and leading quality assurance efforts for medical software products. Ideal candidates will have extensive experience in software quality engineering within regulated environments and will work closely with cross-functional teams to drive quality initiatives.

Benefits

Medical, Vision, and Dental Insurance Plans

401k Retirement Fund

Qualifications

• 8-10 years' experience in Software Quality Engineering.
• Experience with Hazard Analysis (HA) and FMEA.
• Knowledge of FDA regulations and ISO standards.

Responsibilities

• Lead Quality Assurance throughout the Software Development Lifecycle.
• Ensure compliance with FDA and ISO regulations for medical devices.
• Support cybersecurity risk management efforts.

Skills

Attention to detail

Problem-solving

Communication

Analytical skills

Collaboration

Education

Bachelor's degree in Science, Engineering, QA or related field

Tools

JIRA

Confluence

GitLab

Job description

Job Title:Software Quality Engineer
Contract Duration: 6 Months
Pay range: $90/hr
Location:Secaucus, NJ
Work Type: 100% Remote,Monday through Friday - Normal Business Hours. Preference for Eastern or Central Time Zone

Job Description:

• Software Quality Engineer thinks “outside the box” in the implementation of the Software Design Control and Software Quality system programs, providing Quality Assurance and Regulatory oversight, and ensuring compliance with all applicable regulations and incorporation of software industry best practices.

Job Duties & 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 cybersecurity development processes and Cyber Bill of Materials
• This Software Quality Engineer 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 with IEC 62304, and FDA Guidance on Software Contained in a 510(k) and ssPMA Submission
• Support efforts for cybersecurity risk management for both the US and the 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, translating them into system design, system requirements, and sub-system requirements that form the basis of system validation, ensuring sub-systems maintain performance when integrated
• Support development teams in the validation of software development tools
• Provide guidance for the generation, review, and approval of design control documentation with a 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 activities are fully compliant with global medical device regulations and standards.

Required Work Experience:

• 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, IS,O or other regulated environment and/or equivalent combination of education and experience.
• Experience with Hazard Analysis (HA), and Failure Mode and Effects 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).

Preferred Work Experience:

• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
• Experience with software development lifecycles with emphasis on the software quality engineering aspects.

Physical and Mental Requirements:

• Capability to move around the lab space and various environments, including the warehouse, laboratory, and office.
• Strong attention to detail for thorough analysis of quality data and documentation.
• Excellent problem-solving skills to identify and address quality issues effectively.
• Ability to work under pressure and meet deadlines, maintaining accuracy.
• Strong communication skills to collaborate with various teams and present findings effectively.

Required Knowledge:

• Working knowledge of ISO 14971 and/or experience in conducting risk management activities, e.g. hazard analyses, and FMEA
• Experience in the development of system architectures
• Experience with agile SDLC tools such as Atlassian (JIRA, Confluence, and various plug-ins) or GitLab.
• Experience with electronic Quality Management Systems
• Software validation practices, methodologies, and techniques, preferably in validating medical devices.
• Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.
• Experience in leading internal/External audits and regulatory inspections.

Required Skills:

• Effective verbal and written communication skills
• Experience collaborating and communicating with individuals at multiple levels in an organization.
• Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
• Strong analytical and problem-solving skills.
• Able to work effectively in a high-stress, high-energy environment.
• Ability to influence people and projects in a fast-paced environment
• Moving environment.

Required Education:

• Bachelor's degree in science, Engineering, QA, or other related business field.

Preferred Technical Training or Professional Licensing:

• Certified Six Sigma Black Belt
• Certified Six Sigma Green Belt
• Certified Quality Engineer

Travel:

• Limited, but could be up to 25%

Benefits:

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About The Company:
Leading provider of diagnostic information services, empowering healthier lives. Leveraging the world's largest clinical lab database, we offer insights to identify and treat diseases, promote healthy behaviors, and improve healthcare management. Serving millions of patients and healthcare providers worldwide, we're committed to a healthier world, inclusive care, and building value for all stakeholders.

About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!

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