Software Design Assurance Quality Engineer

Philips International; Bengaluru; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

The Software Design Assurance Quality Engineer at Philips drives quality throughout the software lifecycle, ensuring compliance with standards and regulatory requirements while embedding quality in design. The role oversees quality plans, risk management, and post-market analytics, mentoring teams on DFQ, regulatory needs, and QMS.

Collaboration with design, manufacturing, and suppliers ensures timely, compliant releases.

Qualifications

• Bachelor's or Master's degree in Computer Science or equivalent.
• 8–10 years in Software Quality Engineering or related field.
• Experience with SDLC, defect management, and regulatory requirements.

Responsibilities

• Facilitates management of software quality documentation across the lifecycle.
• Leads assessment of software designs for quality, safety, and regulatory compliance.
• Performs root cause analysis to resolve quality deficiencies.
• Validates usability, reliability, performance, and safety inputs.
• Oversees software quality plans and risk management activities.
• Uses post-market analytics to monitor performance and initiate corrective actions.
• Develops Software Quality Plans covering all lifecycle stages.
• Applies global regulations and standards to ensure compliance.
• Presents guidance to teams on schedules, problem solving, and QMS processes.
• Reports quality metrics to stakeholders and identifies improvement opportunities.

Skills

SDLC

Defect Mgmt

Design for Quality

Design Quality Mgmt Cloud

Health IT

Data Analysis

Root Cause Analysis

CAPA

Regulatory Compliance

Privacy & Security

Risk Assessment

Technical Documentation

Continuous Improvement

Product Quality

Design Verification

Design Validation

Test Design

Education

Bachelor's / Master's Degree in Computer Science, Computer Applications or equivalent

Job description

Software Design Assurance Quality Engineer

Job Responsibilities:

• Facilitates the development, maintenance, and management of comprehensive software quality documentation, including Software Requirement Specifications (SRS), ensuring they are accurate, up-to-date, and fully compliant with relevant standards and regulatory requirements throughout the software lifecycle, working under limited supervision.
• Leads the assessment of software designs, including reviewing test and performance data, to ensure they meet quality, safety, and regulatory standards, while identifying and addressing quality engineering deficiencies to embed quality within the design.
• Conducts in-depth root cause analysis for software quality issues, employing problem-solving techniques to resolve deficiencies and improve software design processes, ensuring that quality is integral to the development process.
• Validates key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost to ensure they meet customer and regulatory requirements, supporting the delivery of high-quality software products.
• Provides effective oversight of the execution of software quality plans and associated risk management activities throughout the software lifecycle, ensuring that all design-related activities are managed according to defined processes.
• Utilizes post-market analytics and statistics to monitor software performance in the field, providing feedback to manufacturing, suppliers, and design teams, while initiating corrective actions or field actions when required to maintain software quality.
• Ensures the development of comprehensive Software Quality Plans that cover all stages of the software lifecycle, from design through to post-market, supporting the design of these plans and ensuring adherence to quality and regulatory standards.
• Possesses and applies working knowledge of relevant global regulations, requirements, and standards, ensuring that all quality activities and software design processes comply with applicable regulatory requirements, facilitating compliance throughout the software development lifecycle.
• Acts as a subject matter expert, providing guidance to meet schedules, resolve technical problems, and manage performance requirements, including mentoring on quality engineering practices, regulatory compliance, and QMS processes.
• Monitors, and reports on key software quality metrics, ensuring these metrics are aligned with business objectives and regulatory expectations, while communicating quality-related performance indicators to relevant stakeholders.
• Helps to identify opportunities for process improvements within software quality engineering, advocating for and implementing best practices, tools, and innovative methodologies to enhance software quality and regulatory compliance.

Minimum required Education:

Bachelor's / Master's Degree in Computer Science, Computer Applications or equivalent.

Minimum required Experience:

Minimum 8-10 years of experience with Bachelor's/Master's degree in areas such as Software Quality Engineering or equivalent.

Preferred Skills:

• Software Development Life Cycle (SDLC) - mandatory
• Defect Management - mandatory
• Design for Quality (DFQ) - mandatory
• Design Quality Management Cloud experience preferrable
• Health IT experience
• Data Analysis & Interpretation
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Regulatory Requirements
• Privacy, Safety and Security
• Risk Assessment
• Technical Documentation
• Continuous Improvement
• Product Quality and Reliability
• Design Verification Planning
• Design Validation Planning
• Product Test Design

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture.

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters.

That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights