Design Quality Engineer

Philips; Pune District; On-site; INR 120,000 - 210,000; Full time

Job summary

Philips in Pune, India seeks a Design Quality Engineer to lead design controls, V&V, and design transfer, ensuring regulatory and quality standards are met across the product lifecycle. You will drive risk management, post-market analytics, and internal/external audits, with a focus on ISO13485, FDA 820, and MDR/MDSAP controls.

Fluent English and strong communication are essential. This on-site role requires strong analytical skills, collaboration with cross-functional teams, and a commitment to

Qualifications

• BE in Engineering.
• Minimum 8 years in quality assurance.
• ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP experience.
• Strong communication, problem-solving and continuous improvement.
• Fluent in English (written and spoken).
• Medical or highly regulated industry experience preferred.

Responsibilities

• Lead design input process oversight, V&V activities, design transfer and product realization.
• Support risk management and quality plans across the product lifecycle.
• Perform independent technical assessments of product quality performance.
• Lead quality-related problem solving and post-market analysis.
• Prepare for audits and ensure compliance with CFR 820.30 and ISO13485.

Skills

Quality assurance management

Design control

New product development

Analytical abilities

Communication skills

Problem solving

Continuous improvement

English fluency

Education

BE in Engineering

Job description

Job Title Design Quality Engineer Job Description DQE is responsible for the implementation of comprehensive process validation plans, ensuring smooth transitions of new products to production, working under general supervision. The role supports in the design control process, from validating design inputs to managing verification, validation, and design transfer, ensuring compliance with regulatory and quality standards. The role reviews and refines quality engineering documents, initiates quality improvement projects, and provides expertise in risk management. The role resolves complex quality issues, utilizes post-market analytics for continuous improvement, and prepares for quality audits to maintain adherence to internal and external standards. In this role, you have the opportunity to The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.

You are responsible to Be responsible for the design control in Sustaining Project Quality Assurance Ensures that appropriate Quality Plans are made that include all stages of the life cycle of the product and supports Quality Plan design Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system life cycle Performs independent technical assessment of product quality performance and post-market product quality analysis Can Lead quality related problem-solving and root cause analysis during design and manufacturing Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when required Act as a single point of contact (the person assigned to the project team) responsible for ensuring that hardware design meets quality and compliance standards for every milestone Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. CFR 820.30, and ISO13485. Drive project decision direction toward compliance, cross-functionally and globally. (Process) Ensure that program documentation (Design History File) is created, controlled, and archived per the Quality System. (Process) Lead, prepare, and participate/be the main escort in internal and external audits Frequently interacts with supervisors and functional peer groups. Interaction normally requires the ability to gain the cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

To succeed in this role, you should have the following background, basic skills or experience BE in Engineering Strong quality assurance management experience, minimum 8 years in quality assurance Strong design control and new product development experience Strong analytical abilities Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP Strong communication, problem-solving, and continuous improvement. Fluent in English both in writing and speaking Have experience in the medical industry or highly regulated industry (preferred) Strong Influence Skills, Presentation Skills and Dispute solving Skills.

How we work together

We believe that we are better together than apart. 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 role 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 the lives of others.

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

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.