Design Quality Engineer

Philips

Bengaluru

5-10 Years

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Posted 20 hours ago
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Job Description

As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to alwaysdo the right thing.This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
Ensures success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability.
Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards.
Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
Applies continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle.
Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones.
Minimum Required Qualifications
EducationBachelors / Masters Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
Work ExperienceMinimum 8-10 years of experience with Bachelors in areas such as Quality Engineering, Safety Engineering, R&D Engineering or equivalent OR 5 years experience required with Masters Degree.
Preferred Qualifications
Six Sigma Green Belt
Preferred Skills (Technical / Functional Skills)
Design Quality Management
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
Defect Management
Design Verification Planning
Design Validation Planning
Product Test Design

More Info

Job Type:

Permanent Job

Industry:

Health Care

Role:

Hardware Design Engineer

Function:

Employment Type:

Full time

Open to candidates from:

Indian

About Company

Philips

We are a leading health technology company focused on improving peoples health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care.
We leverage advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.

Job ID: 119808205

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