Apply for Senior Software Quality Engineer Job

6 to 8 Years Relevant Experience

We are seeking a Senior Software Quality Engineer to support and lead quality engineering activities related to non-product software, product software, software tools, and embedded software components. The ideal candidate will have extensive experience in software quality assurance, regulatory compliance, and risk-based QMS processes, particularly in regulated environments such as medical devices or aerospace.

Key Responsibilities

• Review all software-related project deliverables including:
  • Software plans, requirements, and specifications.
  • Verification & validation (V&V) protocols and reports.
  • Test cases, results, traceability matrices, and risk management documentation.
• Provide quality leadership for the verification and validation of:
  • Non-product software (e.g., QMS tools).
  • Embedded product software.
  • Software tools and third-party components.
• Collaborate closely with cross-functional project teams to:
  • Ensure compliance with internal procedures and regulatory requirements.
  • Support design reviews and project phase gates.
  • Influence development of high-quality software specifications and V&V strategies.
• Apply risk management principles to guide software QMS processes in alignment with:
  • ISO 14971 (Risk Management).
  • IEC 62304 (Software Life Cycle).
  • ISO 13485 (QMS for Medical Devices).
• Ensure adherence to relevant regulations and guidance, including:
  • 21 CFR Part 820, 21 CFR Part 11.
  • EU MDR.
  • FDA’s General Principles of Software Validation.
  • IEC 60601-1 (for safety-related systems, if applicable).
• Support internal and external audits by regulatory bodies and ensure audit readiness of software documentation
• Drive continuous improvement of the Quality Management System (QMS) by leveraging audit outcomes, data analysis, and quality objectives

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related technical field.
• Master’s or advanced degree is preferred.
• Minimum of 6 years of experience in software quality assurance, with a focus on:
  • Software testing and verification.
  • Design control within software development lifecycles.
  • Regulatory documentation and compliance.
• Minimum of 3 years of experience in a quality role within a regulated industry such as medical devices, aerospace, or defense.

Desirable Skills and Certifications

• In-depth knowledge of regulatory and quality standards:
  • IEC 62304, ISO 13485, ISO 14971.
  • 21 CFR Part 820, 21 CFR Part 11.
  • IEC 60601-1 (where applicable).
  • European Medical Device Regulation (MDR).
• ASQ certifications such as:
  • Certified Software Quality Engineer (CSQE).
  • Certified Quality Auditor (CQA).
• Strong documentation, communication, and leadership skills in cross-functional environments.