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CSV Validation Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • Today

Full-time

Computer System Validation (CSV) Lead - Oracle Fusion

Algo Soft Solutions LLC

Boston, Massachusetts • 7d ago

Easy Apply

Full-time

55 - 60

Sr Computer Systems Validation Expert (CSV)

SUPERSEVA GLOBAL SERVICES LLC

Norwood, Massachusetts • 2d ago

Easy Apply

Contract

Depends on Experience

CSV Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • Today

Full-time

CSV Engineer (Analyst II)

Katalyst Healthcares and Lifesciences

Cambridge, Massachusetts • Today

Full-time

CSV Systems Engineer III

Curia, Inc.

Hopkinton, Massachusetts • Today

Full-time

USD 122,800.00 - 145,300.00 per year

Validation Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • Today

Full-time

Computer Systems Validation Engineer

CAI

Boston, Massachusetts • Today

Full-time

USD 75,000.00 - 106,000.00 per year

Validation Engineer

Horizontal Talent

Burlington, Massachusetts • Today

Full-time

USD 22.00 - 35.00 per hour

Validation Engineer

Katalyst Healthcares and Lifesciences

Boxborough, Massachusetts • Today

Full-time

CSV Engineer

Katalyst Healthcares and Lifesciences

Woburn, Massachusetts • Today

Full-time

Validation Engineer

Katalyst Healthcares and Lifesciences

Waltham, Massachusetts • Today

Full-time

Job Details

Skills

Data Integrity
Risk Assessment
Impact Analysis
ROOT
FMEA
Decision-making
Forms
Routing
Manufacturing
Document Management
Status Reports
Project Management
Documentation
Dashboard
Metrics Management
Auditing
Management
Continuous Improvement
Regulatory Compliance
Functional Requirements
Mechanical Engineering
Biomedical Engineering
Regulatory Affairs
Computerized System Validation
Verification And Validation
Quality Assurance
Quality Management
QMS
ISO 13485
Corrective And Preventive Action
Medical Devices

Data Integrity
Risk Assessment
Impact Analysis
ROOT
FMEA
Decision-making
Forms
Routing
Manufacturing
Document Management
Status Reports
Project Management
Documentation
Dashboard
Metrics Management
Auditing
Management
Continuous Improvement
Regulatory Compliance
Functional Requirements
Mechanical Engineering
Biomedical Engineering
Regulatory Affairs
Computerized System Validation
Verification And Validation
Quality Assurance
Quality Management
QMS
ISO 13485
Corrective And Preventive Action
Medical Devices

Summary

Job Summary
We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk

Roles & Responsibilities

Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards.
Perform spreadsheet validation activities, including verification of formulas, calculations, data integrity, access restrictions, cell protection, controls, and audit trails.
Support Computer System Validation (CSV) and software validation activities throughout the validation lifecycle.
Support CAPA remediation activities, including corrective action implementation, documentation, and closure.
Develop and support Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages.
Conduct risk assessments, gap assessments, impact analyses, and root cause investigations using tools such as Fishbone, 5-Why, FMEA, and risk-based decision-making methodologies.
Review and update SOPs, forms, templates, work instructions, controlled documents, and other quality system records.
Support alignment of local procedures with global quality and validation requirements.
Manage document control activities, including document revisions, routing, approvals, implementation, and archival requirements.
Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, Supplier Quality, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
Track project milestones, deliverables, risks, issues, dependencies, and CAPA-related actions; provide regular status reports to project leadership.
Prepare and maintain audit-ready documentation packages and CAPA implementation evidence.
nalyze quality data and prepare dashboards, metrics, management reports, and project status updates.
Participate in internal audits, compliance assessments, management reviews, remediation activities, and regulatory readiness initiatives.
Support continuous improvement initiatives focused on strengthening QMS processes, validation compliance, and overall quality system effectiveness.
Ensure all deliverables are completed in accordance with applicable Client Biomet procedures, quality requirements, regulatory expectations, and project timelines.

Education & Experience

Minimum bachelor's degree from an ABET-accredited institution or global equivalent in one of the following disciplines: Mechanical Engineering Technology Biomedical Engineering, Biomedical Engineering Technology
dvanced education or relevant certifications in Quality, Validation, Regulatory Affairs, or Computer System Validation is a plus.
4-6 years of relevant professional experience in medical device quality, CSV, software validation, spreadsheet validation, quality engineering, or a related regulated industry.
Hands-on experience with Medical Device Quality Management Systems (QMS) and regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485.
Experience with CAPA investigation, remediation, implementation, and Verification of Effectiveness (VoE) in a regulated medical device environment.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 2a0d36d16f8c20c184ed6b62f0e72322
Posted 9 hours ago

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CSV Engineer

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Senior Engineer, Quality Engineering

Wilmington, Massachusetts

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Engineering Manager

Danvers, Massachusetts

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We anticipate the application window for this opening will close on - 19 Nov 2026 Position Description: Engineering Manager for Medtronic, Inc. in Danvers, MA. Plan, direct and implement various aspects of the design and development of new medical device products. Develop, evaluate, implement and maintain technical quality assurance and control systems standards in extrusion and assembly manufacturing pertaining to materials, techniques, and products. Select, develop and evaluate personnel to e

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USD 178,000.00 - 213,000.00 per year

Job Details

Skills

Data Integrity
Risk Assessment
Impact Analysis
ROOT
FMEA
Decision-making
Forms
Routing
Manufacturing
Document Management
Status Reports
Project Management
Documentation
Dashboard
Metrics Management
Auditing
Management
Continuous Improvement
Regulatory Compliance
Functional Requirements
Mechanical Engineering
Biomedical Engineering
Regulatory Affairs
Computerized System Validation
Verification And Validation
Quality Assurance
Quality Management
QMS
ISO 13485
Corrective And Preventive Action
Medical Devices

Data Integrity
Risk Assessment
Impact Analysis
ROOT
FMEA
Decision-making
Forms
Routing
Manufacturing
Document Management
Status Reports
Project Management
Documentation
Dashboard
Metrics Management
Auditing
Management
Continuous Improvement
Regulatory Compliance
Functional Requirements
Mechanical Engineering
Biomedical Engineering
Regulatory Affairs
Computerized System Validation
Verification And Validation
Quality Assurance
Quality Management
QMS
ISO 13485
Corrective And Preventive Action
Medical Devices

Summary

Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards.
Perform spreadsheet validation activities, including verification of formulas, calculations, data integrity, access restrictions, cell protection, controls, and audit trails.
Support Computer System Validation (CSV) and software validation activities throughout the validation lifecycle.
Support CAPA remediation activities, including corrective action implementation, documentation, and closure.
Develop and support Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages.
Conduct risk assessments, gap assessments, impact analyses, and root cause investigations using tools such as Fishbone, 5-Why, FMEA, and risk-based decision-making methodologies.
Review and update SOPs, forms, templates, work instructions, controlled documents, and other quality system records.
Support alignment of local procedures with global quality and validation requirements.
Manage document control activities, including document revisions, routing, approvals, implementation, and archival requirements.
Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, Supplier Quality, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
Track project milestones, deliverables, risks, issues, dependencies, and CAPA-related actions; provide regular status reports to project leadership.
Prepare and maintain audit-ready documentation packages and CAPA implementation evidence.
nalyze quality data and prepare dashboards, metrics, management reports, and project status updates.
Participate in internal audits, compliance assessments, management reviews, remediation activities, and regulatory readiness initiatives.
Support continuous improvement initiatives focused on strengthening QMS processes, validation compliance, and overall quality system effectiveness.
Ensure all deliverables are completed in accordance with applicable Client Biomet procedures, quality requirements, regulatory expectations, and project timelines.

Education & Experience

Minimum bachelor's degree from an ABET-accredited institution or global equivalent in one of the following disciplines: Mechanical Engineering Technology Biomedical Engineering, Biomedical Engineering Technology
dvanced education or relevant certifications in Quality, Validation, Regulatory Affairs, or Computer System Validation is a plus.
4-6 years of relevant professional experience in medical device quality, CSV, software validation, spreadsheet validation, quality engineering, or a related regulated industry.
Hands-on experience with Medical Device Quality Management Systems (QMS) and regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485.
Experience with CAPA investigation, remediation, implementation, and Verification of Effectiveness (VoE) in a regulated medical device environment.

Dice Id: 91116760
Position Id: 2a0d36d16f8c20c184ed6b62f0e72322
Posted 9 hours ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Validation Engineer

Boston, Massachusetts

•

Today

Full-time

CSV Engineer

Boston, Massachusetts

•

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Full-time

Senior Engineer, Quality Engineering

Wilmington, Massachusetts

•

Today

Full-time

USD 95,600.00 - 131,450.00 per year

Engineering Manager

Danvers, Massachusetts

•

Today

Full-time

USD 178,000.00 - 213,000.00 per year