Senior Quality Engineer

MedAcuity

. Represent Quality Engineering as a core team member in verification, validation planning, and risk analysis .

Posted 11/7/2026full-timeWestford • Massachusetts • United StatesSenior💰 $120,000 - $135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Engineering with a focus on verification, validation, and risk analysis, while ensuring compliance with FDA QSRs and ISO standards. Proficient in developing and executing comprehensive testing strategies, including automation frameworks and statistical methods.

Highest-signal resume keywords

Quality Testing ExperienceTest Automation FrameworksStatistical Methods ExpertiseFDA QSRs KnowledgeAgile Methodologies Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality EngineeringTest AutomationStatistical MethodsRegression TestingIntegration TestingPython ScriptingDefect TrackingTest Driven DevelopmentBehavioral Driven DevelopmentRequirements Management

Soft Skills

Technical WritingAdaptabilityInitiative

Tools & Technologies

PytestRobotTestCompleteSquishGITHelixALMJama

Industry Keywords

FDA QSRsISO 13485IEC 62304IEC 60601ISO 14971

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

Represent Quality Engineering as a core team member in verification, validation planning, and risk analysis
Contribute to process validation, design verification, and design validation
Provide input on statistical methods, test methodologies, test facilities, and test equipment
Contribute to validation of software and/or production tools
Develop and maintain Quality Plans throughout the product life cycle from project inception/initiation
Develop and execute regression, acceptance, integration, performance, load, system-level, and reliability testing
Assist with issue resolution and failure investigations
Conduct internal audits as assigned
Maintain and comply with MedAcuity/client SOPs
Review procedures for adequacy in software and device development and conformity with business and Quality Management System requirements
Refine requirements for testability, gaps, and clarity
Drive quality analysis and coordinate verification and validation plans

Requirements

What you’ll need

8+ years of experience in quality testing
Expertise with defect tracking and metrics
Experience designing, developing, and implementing test automation frameworks such as Pytest, Robot, TestComplete, and Squish
Strong technical writing skills, including development of test methods, protocols, and reports
Expertise with scripting languages such as Python
5+ years of professional experience with GIT revision control and software development methodologies
Understanding of Test Driven Development, Behavioral Driven Development, and data-driven test practices
High sense of adaptability and initiative
Knowledge of requirements management software such as Helix, ALM, and Jama
Strong working knowledge of FDA QSRs, ISO 13485, IEC 62304, IEC 60601, and ISO 14971 requirements
Experience with Agile and SCRUM methodologies
Prior experience in a consulting capacity
Bachelor’s Degree in Computer Science or a related discipline, or equivalent years of experience in a comparable role

Benefits

Comp & perks

Discretionary performance-based bonus based on personal and company factors
Medical, dental and vision insurance
Health Reimbursement Arrangement (HRA)
Flexible Spending Accounts
401(k) with company match
Company-paid life and disability insurance
Additional voluntary life insurance
Employee assistance programs
Recognition awards
Competitive vacation and sick time allowances
Company holidays
Healthy work-life balance prioritized