Software Quality Engineer I

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

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Department: Quality Systems & Compliance

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

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, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

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.

Knowledge, Skills and Abilities (KSA)

• Quality and business process knowledge:
• 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.

Qualifications/ Background Experiences

• 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.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, 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.