Software Quality Sr Engineer

Zimmer Biomet; United States; Remote; USD 100,000 - 124,000; Full time

Job summary

Zimmer Biomet is seeking a Software Validation and Quality Sr Engineer to support regulated software activities. This remote role focuses on validation, quality review, audit readiness, and compliance with FDA, IEC, ISO standards across embedded and cloud-based systems.

You will lead validation planning, create protocols, perform traceability, and collaborate with R&D, QA, and Regulatory teams to ensure robust software quality and regulatory readiness.

Qualifications

• Bachelor's Degree and 4 years of relevant experience or equivalent
• Preferred: BS in computer science, computer engineering, or related field
• 4+ years of software validation and quality experience in a regulated environment (medical device preferred)
• Familiarity with regulatory standards including FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11
• Strong understanding of V&V principles, test coverage and objective evidence
• Experience working with cross-functional teams (R&D, QA, Regulatory)

Responsibilities

• Perform software quality review of requirements, design, and deliverables to ensure compliance with FDA, ISO and IEC 62304 standards
• Ensure adherence to quality system processes and design control requirements across the software development lifecycle
• Review and approve requirement specifications, test plans, validation protocols, RTMs, and validation reports
• Support requirements activities ensuring clarity, completeness, and testability of software requirements
• Ensure end-to-end traceability between requirements, risk controls, and verification evidence
• Participate in risk assessments and ensure proper implementation and verification of risk control measures
• Participate in design reviews, code reviews, and quality reviews of software deliverables
• Support change management activities, including impact assessment and documentation of software changes
• Support V&V activities by developing and executing test plans, test cases, and validation protocols
• Perform functional, integration, and system-level testing for embedded software and cloud-based systems
• Prepare and review validation documentation including test plans, protocols, reports, and compliance records
• Support defect investigations for root-cause analysis and closure
• Support audit readiness activities and regulatory inspections (FDA, ISO)

Skills

Software Validation

Software Quality Review

Regulated Environments

Audit Readiness

Test Planning

Risk Management

Regulatory Standards

Cross-functional Collaboration

Education

Bachelor's degree in Computer Science/Engineering

4+ years software validation in regulated environment

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

What You Can Expect

The Monogram Technologies Team at Zimmer Biomet is seeking a detail-oriented Software Validation and Quality Sr Engineer experienced in regulated environments, specializing in software quality review, compliance, and audit readiness, with hands-on capability in validation and testing activities supporting FDA, IEC and ISO standards.

This is a remote position.

How You'll Create Impact

• Perform software quality review of requirements, design, and deliverables to ensure compliance with FDA, ISO and IEC 62304 standards.
• Ensure adherence to quality system processes and design control requirements across the software development lifecycle.
• Review and approve requirement specifications, test plans, validation protocols, traceability matrices (RTM), and validation reports.
• Support requirements activities by ensuring clarity, completeness, and testability of software requirements.
• Ensure end-to-end traceability between requirements, risk controls, and verification evidence.
• Participate in risk assessments and ensure proper implementation and verification of risk control measures.
• Participate in design reviews, code reviews, and quality reviews of software deliverables.
• Support change management activities, including impact assessment and documentation of software changes.
• Support validation and verification (V&V) activities by developing and executing test plans, test cases, and validation protocols as needed.
• Perform functional, integration, and system-level testing for embedded software and cloud-based systems to support product quality.
• Prepare and review validation documentation including test plans, protocols, reports, and compliance records.
• Support defect investigations to ensure proper root cause analysis and closure.
• Support audit readiness activities and regulatory inspections (FDA, ISO).

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act

What Makes You Stand Out

• Strong understanding of software verification and validation (V&V) principles, including test coverage and objective evidence.
• Experience with validation deliverables including test plans, validation protocols, execution reports, and RTM.
• Familiarity with risk management processes and participation in risk assessments (ISO 14971).
• Experience with change management processes and impact assessment.
• Familiarity with configuration management practices, including version control and release traceability.
• Experience in design reviews, code reviews, and quality reviews of software systems.
• Knowledge of regulatory standards including FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
• Prior experience working with cross-functional teams including R&D, QA, and Regulatory.

Your Background

• Minimum Requirements: Bachelor's Degree and 4 years of relevant experience or equivalent experience
• Preferred Experience:
  • Bachelor’s degree in computer science, computer engineering, or a related field.
  • 4+ years of software validation and quality experience in a regulated environment (medical device preferred).

Travel Expectations

Up to 10%

Expected Compensation Range

$100,000 - $124,000 USD / Annual

EOE