Software Quality Engineer

The Software Quality Engineer (SQE) within Quality and Regulatory organization plays a critical role in ensuring that software whether embedded in products, supporting clinical workflows, or used in enterprise quality systems meets rigorous internal quality standards and global regulatory requirements.

The SQE is responsible for driving and executing software validation activities across the development lifecycle, contributing to design control, risk management, and audit readiness initiatives to maintain the integrity, reliability, and compliance of all GxP-relevant software systems.

The ideal candidate will be within range of a major Quest site. Sites include Secaucus, NJ, Clifton, NJ, Marlborough, MA, Wood Dale, IL, Lenexa, KS, Dallas, TX, Pittsburgh, PA, and Houston, TX.

Design Control & Risk Management

• Ensure all software development activities comply with FDA 21 CFR Part 820 and ISO 13485
• Participate and contribute to Design inputs/outputs reviews, verification and validation planning, Design transfer, and Design history file compilation.
• Lead or contribute to hazard analysis and risk assessment using ISO 14971

Validation Testing and Documentation

• Ensure documentation is complete, reviewable, and audit ready.
• Collaborate with Document Control to ensure controlled documents (SOPs, test records, validation packages) are managed appropriately.
• Ensure all documents are compliant with company policy, regulation requirements, and standards.
• Maintain hard copy records in accordance with Quest's retention policy.
• Create standard templates for validation and testing deliverables.
• Author and revise procedures and work instructions related to SDLC, validation lifecycle, change control, and risk management.

Software Validation (CSV/SDLC)

• Develop validation plans for LIMs, QMS software, and other GxP Systems
• Define and execute User Requirements Specifications (URS), Functional and configuration specifications, IQOQPQ protocols, and test scripts (Manual and automated)
• Oversee software risk classification and mitigation plans.
• Drive generation and preparation of documentation, records, and other artifacts in support of regulatory submissions.
• Perform process audits and implement improvements to reduce cycle times and increase validation efficiency.
• Lead root cause analysis for software nonconformances, validation failures, defect leakage to production.
• Participate in audits

Required WorkExperience:

• 5+ years of experience in Software Development and Validations in medical device and/or IVD industry.
• Hands-on experience with software validation (CSV) including authoring, review, and root-cause analysis of validation deliverables.
• Lead experience on validation projects and ownership of full software validation lifecycle.
• Demonstrated Experience applying Medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15189, IVDR, CAP, and CLIA).

Preferred Work Experience:

• Experience with IEC 62304- Software Lifecycle for Medical Devices
• Experience validation cloud-bases systems (e.g. SaaS Platforms, AWS)
• Experience with Cybersecurity validation, secure SDLC, or Software as a medical device (SaMD)
• Experience with EU MDR/IVDR and international regulatory submissions
• Experience with eQMS systems such as MasterControl, Trackwise, or Veeva
• ASQ CSQE (Certified Software Quality Engineer) or medical device related certification, or CSV/GAMP 5 training

Physical and Mental Requirements:

• Strong attention to detail for thorough documentation to ensure consistency in documentation.
• Excellent problem-solving skills to identify and address quality issues effectively.
• Ability to manage multiple work projects to meet deadlines while maintaining accuracy.
• Must be able to occasionally move and lift objects of up to 25 pounds.

Knowledge:

• Broad-based technical knowledge and skills of software validation principles in regulated environment, design controls, risk management (ISO 14071).
• Demonstrated knowledge for software development lifecycle models (waterfall, Agile, V-model)
• Strong working knowledge of applicable regulations, such as but not limited to, the medical device regulations: FDA 21 CFR Part 820 Quality Systems Regulations/new Quality Management System Regulation and ISO 13485 standards. Preferred: ISO 14971, ISO 15189, IVDR, CAP, CLIA, and NYSDOH requirements.

Skills:

• Computer System Validation of software used in regulated environments following GAMP 5 and FDA 21 CFR Part 11
• Test planning and Execution including writing test protocols and executing manual or automated testing.
• Building requirements traceability matrices
• Applying risk-based validation based on ISO 14071 and GAMP principles to prioritize validation efforts.
• Ability to work independently and collaboratively with cross-functional departments in a fast-paced environment with minimal supervision.
• Proficient in document management systems.