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CSV Validation Engineer

Boston, MA, US • Posted 8 hours ago • Updated 8 hours ago

Full Time

On-site

Fitment

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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 8 hours ago

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