Service & Delivery Quality Process Engineer

Philips

. Work and report directly to the Head of Quality Radiology Informatics .

Posted 10/18/2026full-timeCambridge • Massachusetts • United StatesMid-LevelSenior💰 ₪15,000 - ₪26,000 per monthWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) within the medical device industry, focusing on software quality engineering, regulatory compliance, and process improvement. Proficient in facilitating audits, corrective actions, and risk management while effectively communicating across global teams.

Highest-signal resume keywords

Quality Management System (QMS)Software Quality EngineeringISO13485 / MDSAP / MDD & EU-MDR / CFR FamiliarityCorrective and Preventive Actions (CAPA)Data Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System (QMS)Software Quality EngineeringRoot-Cause AnalysisProcess ImprovementRegulatory ComplianceRisk ManagementData AnalysisMulti-Location Project LeadershipQuality AuditsTechnical Documentation

Soft Skills

Effective Interpersonal SkillsStrong Oral CommunicationPresentation SkillsSelf-StarterMotivated

Tools & Technologies

ExcelPowerPointWordIT Tools

Certifications & Qualifications

PMP Certification

Industry Keywords

Medical Device IndustrySoftware as a Medical DeviceQuality AssuranceQuality ControlRegulatory Scope

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Work and report directly to the Head of Quality Radiology Informatics
Work with the extended PSQ and Markets Q&R teams
Execute tactical cross-functional Quality activities and projects supporting customer needs, RI strategy implementation, and EI business success
Support implementation of Quality transformation projects
Facilitate, participate in, and communicate QMS service activities and projects between departments, sites, and businesses
Initiate, stimulate, and support process improvements
Facilitate, manage, and support internal and external audits across business processes
Support and advise the organization on corrective and preventive actions (CAPA)
Participate in maintaining and improving the Quality Management System
Facilitate and participate in applying risk management tools, assessments, processes, and principles
Translate regulations and standards and consolidate them within the organization and Quality Management System
Participate in and verify changes to the QMS impacting service
Perform timely software Quality Engineering tasks, including assessing software design and reviewing tests and performance data
Analyze market feedback and complete or assist with root-cause analysis and software Quality problem solving
Interact with local and global functions across multiple businesses

Requirements

What you’ll need

Bachelor's degree – preferred software / technical / engineering background
5+ years of experience in Q&R roles within medical device industry, including software as a medical device
Familiarity with relevant standards and regulations, e.g., ISO13485 / MDSAP / MDD & EU-MDR / CFR
Experience in leading multi-location activities and projects under a regulatory scope
Effective interpersonal and communication skills
Strong oral and presentation skills in English
Familiarity with problem-solving techniques and root-cause analysis
Experience with Excel, PowerPoint, and Word; capable of acquiring further IT tools ability
Self-starter, motivated, and energetic
PMP Certification – preferred
Data analysis knowledge and experience – preferred
Experience with service and delivery of software – highly preferred

Benefits

Comp & perks

Bonus eligibility, with rewards linked to KPIs and company results
Additional benefits shared during the interview process