Software Quality Engineer I
Terumo
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).
Job description
Job Details/Responsibilities
- 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)
- 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.
Requirements
- 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
- Annual Bonus
- Paid Vacation
- Paid Holidays
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Matching
- Tax Advantage Savings Accounts
- Legal Plan
- Voluntary Life Insurance
- AD&D Insurance
- Voluntary Long-Term Disability
- Short Term Disability
- Critical Illness Insurance
- Accident Insurance
- Parental Leave
- Personal Leave
- Tuition Reimbursement
- Travel Assistance
- Employee Assistance Program
Company overview
Terumo Corporation is a global leader in medical technology with over 100 years of history, founded in 1921 as a Japanese thermometer manufacturer. Headquartered in Tokyo and listed on the Tokyo Stock Exchange (TSE: 4543), Terumo operates in more than 160 countries and regions worldwide with approximately 30,000 employees. The company's extensive business portfolio spans three major segments: Cardiac & Vascular Business, Blood Management Business, and General Hospital Business. Terumo specializes in innovative medical solutions including vascular intervention systems, cardiovascular surgical devices, neurovascular treatment technologies, blood transfusion systems, diabetes care products, peritoneal dialysis equipment, and various disposable medical devices. As a component of the Nikkei 225 index, Terumo has grown through strategic acquisitions including Vascutek, MicroVention, and CaridianBCT, establishing itself as a comprehensive medical device manufacturer with strong R&D capabilities and global manufacturing footprint. The company maintains its founding mission of "Contributing to Society through Healthcare" while continuously advancing medical technology to improve patient outcomes and healthcare delivery worldwide.