MES Quality Engineer — Validation & Compliance Specialist

Terumo Medical Corporation; Elkton (MD); On-site; USD 68,000 - 90,000; Full time

Benefits offered by this job

Health, dental and vision benefits

401(k) with matching contributions

Paid vacation and holidays

Job summary

Terumo Medical Corporation is seeking a Software Quality Engineer I to support MES deployments, sustaining, and optimization, ensuring software validation and eDHR integrity in a regulated environment.

The role covers planning, reviews, and execution of validation activities in line with 21 CFR Part 11, ISO 13485, and GAMP 5, contributing to high-quality medical device manufacturing processes.

Qualifications

• Effective communication (written and verbal).
• Attention to detail and commitment to quality.
• Strong proofreading and writing skills.
• Strong organizational and prioritization skills.
• Ability to multitask, prioritize, and deliver within deadlines.

Responsibilities

• Develops software validation strategies for new and revised quality system and manufacturing software.
• Reviews and approves validations, test scripts, and reports.
• Supports continuous improvement of software validation and controls processes.
• Interprets risk-based techniques for software validation and controls.
• Supports MES deployments, sustaining, and optimization projects.
• Maintains compliance of MES system and eDHR.

Skills

Communication

Attention to detail

Proofreading

Organization

Multitasking

Teamwork

Education

Associate’s degree in engineering or science

Tools

MS Office

Job description

Terumo Medical Corporation is seeking a Software Quality Engineer I to support MES deployments, sustaining, and optimization, ensuring software validation and eDHR integrity in a regulated environment.

The role covers planning, reviews, and execution of validation activities in line with 21 CFR Part 11, ISO 13485, and GAMP 5, contributing to high-quality medical device manufacturing processes.