Software Quality Engineer I

Terumo Medical Corporation

. Develop software validation strategies for new and revised quality system and manufacturing software .

Posted 9/29/2026full-timeElkton • Maryland • United StatesJuniorMid-Level💰 $68,000 - $90,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computerized System Validation (CSV) and compliance with regulatory standards such as 21 CFR Part 11 and ISO 13485. Proficient in developing validation strategies, test cases, and maintaining the integrity of electronic device history records (eDHR) within the medical device and pharmaceutical industries.

Highest-signal resume keywords

Computerized System Validation (CSV)21 CFR Part 11 ComplianceISO 13485 KnowledgeManufacturing and Quality System PrinciplesMES Validation Test Case Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Validation StrategiesTest Case ExecutionValidation Plans CreationRisk-Based TechniquesData Integrity PrinciplesComputer Software Assurance (CSA)ALCOA+ PrinciplesValidation Protocols ReviewContinuous Improvement ProcessesManufacturing Software Compliance

Soft Skills

Effective CommunicationAttention to DetailOrganizational SkillsMultitasking AbilityTeam Collaboration

Tools & Technologies

MS OfficeManufacturing Execution Systems (MES)

Industry Keywords

Medical Device IndustryPharmaceutical IndustryGAMP 5Quality System RegulationsProcess Validation

About the role

Key responsibilities & impact

Develop software validation strategies for new and revised quality system and manufacturing software
Provide guidance and support throughout software validation projects
Review and approve validations, test scripts, and reports
Support continuous improvement of software validation and controls processes in accordance with regulatory requirements
Interpret and provide guidance on risk-based techniques for software validation and controls
Function as an integrated MES team member supporting new MES deployments, sustaining, and optimization projects
Assist with development of MES validation test cases
Support Software Verification & Validation activities, including CRS revisions and test case execution
Support maintenance of MES compliance and its validated state
Maintain the integrity of the electronic device history record (eDHR)
Create validation plans, review and approve software changes, review validation protocols and reports, develop requirements, revise or create procedures, author MES and software validation/sustainment test cases, and execute test cases

Requirements

What you’ll need

Associate’s degree required in engineering or a scientific discipline or equivalent combination of education and experience
Minimum of 2 years relevant Computerized System Validation (CSV) experience, or 1 year CSV and 1 year relevant Process Validation experience in the medical device/pharmaceutical industry
Experience with 21 CFR Part 11 and GAMP 5 computer system validation and control requirements
Experience with 21 CFR Part 820 and ISO 13485
Experience with manufacturing and quality system principles
Knowledge of MES and its role in an organization
Knowledge of Computer Software Assurance (CSA) principles
Knowledge of ALCOA+ and Data Integrity principles
Effective written and verbal communication
Ability to follow established procedures
Attention to detail and commitment to quality
Strong proofreading and writing skills
Strong organizational and prioritization skills
Ability to multitask, prioritize, and provide deliverables within the required time period
Strong computer knowledge, including MS Office
Ability to work as a team member on cross-functional teams and with associates across all levels within the organization

Benefits

Comp & perks

Annual bonus
Paid vacation
Paid holidays
Health benefits
Dental benefits
Vision benefits
401(k) with matching contributions
Tax advantage savings accounts
Legal plan
Voluntary life and AD&D insurance
Voluntary long-term disability insurance
Short-term disability insurance
Critical illness insurance
Accident insurance
Parental leave
Personal leave
Tuition reimbursement
Travel assistance
Employee assistance program