Product Quality Engineer

Philips; Bengaluru; On-site; INR 3,500,000 - 5,200,000; Full time

Job summary

Philips seeks a Product Quality Engineer to support design controls and quality management for medical device development and sustaining initiatives. You will lead Design History Files, drive quality norms, and integrate risk management across the product lifecycle.

You will also support post-market surveillance, CAPA/QA improvements, audits, and regulatory submissions, collaborating with cross-functional teams in a global framework.

Qualifications

• Bachelor's/Master's degree in Mechanical or Electronics Engineering, Science or equivalent.
• Minimum 8–10 years of quality engineering, R&D or related experience.
• Preferred Six Sigma Green Belt certification.

Responsibilities

• Lead all quality elements of Design Controls and product Design History Files.
• Drive Quality norms for design engineering projects and risk management integration.
• Support post market surveillance, field data analysis and CAPA initiatives.
• Coordinate audits, regulatory submissions support and QMS improvement efforts.

Skills

Design Quality Management

ISO 14971

21 CFR 820

ISO 13485

EU MDR

IEC 60601-1

IEC 62366

IEC 62304

Data Analysis

CAPA Methodologies

RCA

PLM

Regulatory Requirements

Education

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

Job description

Job Title: Product Quality Engineer

Job Description

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.

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

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.