Full time

Work From Office

This Position is Currently Open

Department / Category:

Engineer

Listed on Jul 25, 2025

Work Location:

Kolkata

Bangalore

Job Descritpion of Senior Software Quality Engineer

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).

- Solid documentation, communication, and leadership skills in cross-functional environments.

Required Skills for Senior Software Quality Engineer Job

- ASQ certification
- software testing
- design control of software development
- software verification and validation

Our Hiring Process

- Screening (HR Round)

- Technical Round 1

- Technical Round 2

- Final HR Round

📌 Senior Software Quality Engineer (India)
🏢 Phygital Insights
📍 India