Software Quality Engineer I: MES Validation & Compliance

Terumo Cardiovascular Group; Elkton, Northern (MD, KY); Hybrid; USD 68,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Paid vacation

Paid holidays

Health benefits

Dental benefits

Vision benefits

401(k) with match

Tax-advantaged savings accounts

Life/AD&D insurance

Job summary

Terumo Medical Corporation in Elkton, MD is seeking a Software Quality Engineer I to support MES deployments, sustaining, and optimization, and to validate software that underpins the quality system, manufacturing, and distribution.

You will develop validation plans, review protocols, write test cases, execute tests, and help maintain the eDHR and compliant state of the MES, following 21 CFR Part 11, GAMP 5, and ISO 13485 requirements.

Qualifications

• 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) or 1 year CSV and 1-year 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.
• Experience in medical device industry is preferred.

Responsibilities

• Support deployment, sustaining, and optimization of the MES.
• Create validation plans and review validation protocols and reports.
• Develop MES validation test cases and support Software Verification & Validation activities.
• Maintain the compliance of the MES system and the integrity of its validated state and the eDHR.
• Provide risk-based guidance for software validation and controls.

Skills

Quality knowledge

MES validation

CSA principles

Data integrity

Communication

Documentation

Teamwork

Attention to detail

MS Office

Education

Associate degree in engineering or scientific discipline

Tools

MS Office

Job description

Terumo Medical Corporation in Elkton, MD is seeking a Software Quality Engineer I to support MES deployments, sustaining, and optimization, and to validate software that underpins the quality system, manufacturing, and distribution.

You will develop validation plans, review protocols, write test cases, execute tests, and help maintain the eDHR and compliant state of the MES, following 21 CFR Part 11, GAMP 5, and ISO 13485 requirements.