Product Quality Engineer

Philips Iberica SAU; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Philips Iberica SAU is seeking a Product Quality Engineer to lead quality elements of Design Controls and maintain Design History Files. You will drive quality norms across design projects and support risk management throughout the product lifecycle, including post-market surveillance and CAPA initiatives.

Role requires strong experience in regulatory requirements, data analysis, and quality documentation. You will collaborate with regulatory affairs and supplier quality teams while ensuring

Qualifications

• Bachelor's or Master's degree in a relevant engineering field or science.
• 8–10 years of experience in Quality Engineering, R&D or related area.
• Six Sigma Green Belt preferred.
• Experience with ISO 14971, 21 CFR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, IEC 62304.

Responsibilities

• Lead all quality elements of Design Controls and product Design History Files.
• Drive quality norms across design engineering projects.
• Support risk management throughout the product lifecycle and post-market surveillance.
• Lead CAPA and QMS continuous improvement initiatives.
• Coordinate regulatory submissions and audits as needed.

Skills

Design Controls

Risk Management

CAPA

Data Analysis

Regulatory Requirements

Root Cause Analysis

Quality Documentation

Education

Bachelor's or Master's in Mechanical Engineering

Electronics Engineering

Science

Tools

PLM

ISO Standards

Regulatory Databases

Job description

Job Title

Product Quality Engineer

Job Description

Job Title : 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.

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