Product Quality Engineer

Philips International; Bengaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Philips is seeking a Product Quality Engineer to lead design controls, risk management, and quality system integration across development, transfer, and sustaining initiatives for medical devices. You will drive CAPA and QMS improvements, support regulatory submissions, and collaborate with cross-functional teams to ensure compliance and product quality.

The role emphasizes leading design quality, post-market surveillance analysis, and ensuring adherence to ISO 14971, 21 CFR 820, and related

Qualifications

• Bachelor's or Master's in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• Minimum 8-10 years in Quality Engineering, Safety Engineering, R&D Engineering or equivalent.

Responsibilities

• Lead all quality elements of Design Controls and product Design History Files.
• Lead Quality Plan initiatives associated with Risk Management and Quality System integration.
• Analyze situations/data to identify gaps between project work and QMS.
• Transfer quality deliverables for new products to manufacturing, operations quality and supplier quality teams.

Skills

Design Quality Management

CAPA Methodologies

Root Cause Analysis

Regulatory Requirements

Data Analysis

Quality Systems

PLM

Education

Six Sigma Green Belt

Tools

DFQ

CAPA Tracking

ISO Standards

Job description

Product Quality Engineer

The Product Quality Engineer will support design controls and quality management associated with the development, transfer and sustaining initiatives for the medical devices. You are responsible for Lead all quality elements of Design Controls and product Design History Files. Drive Quality norms associated with design engineering projects. Support integration of Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with Philips processes and global standards. Lead Quality Plan initiatives associated with Risk Management and Quality System integration. Support integration of post market surveillance processes into Design Controls and Sustaining initiatives through analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues. Support the Regulatory Affairs department for submissions and respond to submission questions. Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives. Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS. Transfer Quality deliverables for new products and sustaining projects to manufacturing and operations quality and supplier quality teams. Support internal and external audits. Acts in full compliance to all applicable regulatory requirements and Philips Quality policies.

Your role:

• Lead all quality elements of Design Controls and product Design History Files.
• Lead Quality Plan initiatives associated with Risk Management and Quality System integration.
• Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS.
• Transfer Quality deliverables for new products and sustaining projects to manufacturing and operations quality and supplier quality teams.

Minimum required Education:

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.

Minimum required Experience:

Minimum 8-10 years of experience with Bachelor's/Master's in areas such as Quality Engineering, Safety Engineering, R&D Engineering or equivalent.

Preferred Certification:

Six Sigma Green Belt

Preferred Skills:

Design Quality Management Experience in ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards - Mandatory Data Analysis & Interpretation Design for Quality (DFQ) Root Cause Analysis (RCA) CAPA Methodologies Regulatory Requirements Privacy, Safety and Security Risk Assessment Technical Documentation Continuous Improvement Product Quality and Reliability Product Lifecycle Management (PLM) People Management Defect Management Design Verification Planning Design Validation Planning Product Test Design

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. Indicate if this role is an office/field/onsite 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.

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