Service and Delivery Quality Process Engineer – Philips

Location: Bengaluru, Karnataka
Job Type: Full-time (Office-based)

About Philips

Philips is a global leader in health technology, committed to improving lives through innovative medical solutions. Our mission is to ensure everyone has access to quality healthcare. Join us in transforming healthcare and making a difference in millions of lives.

Role Overview

As a Service and Delivery Quality Process Engineer, you will be a crucial part of a dynamic team developing Software as a Medical Device (SaMD). This role is fundamental to the Quality organization under the Radiology Informatics Business Unit (RI BU), ensuring regulatory compliance, process improvement, and quality system maintenance.

You will collaborate with cross-functional teams to support customer needs, regulatory strategy execution, and business success while driving quality transformation projects.

Key Responsibilities

✔ Quality Management & Process Improvement

• Lead and support Quality Management System (QMS) activities across multiple departments, locations, and business units.
• Initiate, facilitate, and implement process improvement initiatives to enhance service delivery and compliance.
• Support internal and external audits across all business processes.

✔ Regulatory Compliance & Risk Management

• Ensure compliance with ISO 13485, MDSAP, EU MDR, CFR and other relevant regulatory standards.
• Interpret regulations and standards, integrating them into quality and compliance processes.
• Support and validate QMS changes that impact services.
• Apply risk management tools and methodologies to assess and mitigate risks effectively.

✔ Corrective & Preventive Actions (CAPA) Management

• Support and advise teams on corrective and preventive actions (CAPA) to ensure continuous improvement.
• Conduct root cause analysis and problem-solving techniques to resolve quality issues.
• Analyze market feedback and performance data to drive quality improvements.

✔ Software Quality Engineering

• Review software design, test results, and performance data to ensure compliance with regulatory standards.
• Collaborate with local and global teams to enhance software delivery and service quality.

Preferred Skills & Experience

???? Must-Have:

• Bachelor’s degree (Preferred in Software/Technical/Engineering disciplines).
• 8-10 years of experience in Quality & Regulatory (Q&R) roles within the medical device industry, including Software as a Medical Device (SaMD).
• Strong knowledge of ISO 13485, MDSAP, MDD, EU MDR, CFR and other regulatory frameworks.
• Experience managing multi-location activities and regulatory projects.
• Problem-solving expertise with a background in root cause analysis (RCA) techniques.
• Effective communication and stakeholder management skills (English proficiency required).

???? Good to Have:

• PMP Certification (Preferred).
• Data analytics knowledge and experience.
• Experience with service and delivery of software.
• Proficiency in Excel, PowerPoint, Word, with the ability to learn new IT tools.

Work Environment & Culture

???? Hybrid & On-Site Work

• Office-based role with an expectation to work in-person at least 3 days a week.

???? Diversity & Inclusion

• Philips values diversity, inclusion, and equal opportunity. We encourage candidates from all backgrounds to apply, even if they don’t meet every requirement.

???? Career Growth & Impact

• Work at the forefront of healthcare innovation, developing life-changing medical technologies.
• Shape the future of healthcare while enhancing your skills in quality, compliance, and process improvement.

How to Apply?

???? Submit your application via our official Philips Careers page.

???? Not sure if you meet all the requirements? If you’re passionate about this role and believe you can contribute, apply anyway—we’d love to hear from you!

Join Philips and be part of a team where innovation, quality, and healthcare transformation come together! ????

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