Software Quality Engineer

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

Software Quality Engineer I is a dual-purpose role that supports new deployments, sustaining, and/or optimization of the Manufacturing Execution System (MES) and the validation / sustainment of software that supports the quality system, manufacturing, distribution, and other GXP-related functions. This includes creating validation plans, reviewing and approval of software changes, and reviewing validation protocols/reports and developing requirements, revising/creating procedures, authoring MES and software validation / sustainment test cases, executing test cases and maintaining the integrity of the electronic device history record (eDHR).

• Develops software validation strategies for new and revised quality system and manufacturing software. Works with the team to provide appropriate guidance and support throughout the projects. Reviews and approves validations, test scripts, and reports.
• Supports the continuous improvement of TMC’s software validation and controls processes in accordance with regulatory requirements.
• Interprets and provides guidance on appropriate risk-based techniques for software validation and controls.
• Functions as an integrated MES team member to support new MES deployments, sustaining, and optimization projects.
• Assists with development of MES validation test cases and support Software Verification & Validation activities that include CRS revisions and test case execution.
• Supports the maintenance for the compliance of the MES system, the integrity of its validated state, and the eDHR.

Position Requirements:

• Knowledge of MES and its role in an organization.
• Knowledge of Computer Software Assurance (CSA) principles.
• Knowledge of ALCOA+ and Data Integrity principles.
• Effective communication (written and verbal).
• 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 (MS Office).
• Ability to work as a team member on cross-functional teams and with associates across all levels within the organization.
• 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 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.
• Experience in medical device industry is preferred.

Benefits and Compensation:

We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Salary range is $68,000 - $90,000 per year.

Employee Value Proposition:

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver’s seat – progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what’s next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, sustainable solutions for patients.

Join us, and help shape wherever we go next!