Systems Quality Engineer II
Elkton, MD, US
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
The Systems Quality Engineer II will support the implementation and improvement of the integrated quality management system to ensure it is compliant with applicable global Quality System regulations (i.e., 21 CFR Part 820, ISO 13485:2016, MDR etc.). They will ensure that the solutions are effective and efficient while also providing functional and technical support to the project team.
Job Details/Responsibilities
- Support the design, development, maintenance and continuously improve the TMC Quality System in accordance with applicable regulations for a global medical device corporation.
- Help to establish user and system requirements.
- Support the definition and validation of user and system requirements to ensure the successful implementation and performance of the electronic Quality Management System (eQMS)
- Gather and analyze data to support effective planning for the implementation of the electronic quality management system (eQMS).
- Leverage data analytics to inform planning and optimize the implementation of the electronic Quality Management System (eQMS), ensuring alignment with organizational goals and regulatory requirements.
- Provide technical and functional expertise to teams before, during and after implementation phases.
- Provide exceptional user support during the planning and execution of implementation phases
- Contribute to the development of Quality System Standard Operating Procedures, Work Instructions and training materials as required.
- Contribute to the development of Quality System performance metrics to demonstrate performance of the quality system.
- Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
- Other duties as assigned.
Job Responsibilities (continued)
Working Conditions/Physical Requirements
Knowledge, Skills and Abilities (KSA)
- Knowledge in 21 CRF Part 820, ISO 13485:2016, Medical Device Directive / Regulation.
- Strong computer knowledge (MS Office), technical writing skills and proofreading ability.
- Ability to develop, communicate, and support the implementation of comprehensive quality systems.
- Ability to analyze data utilizing Power BI, Excel, Minitab, or other data analytical software.
- Ability to navigate implementing products and processes in an efficient and compliant manner.
- Demonstrated ability to interact cross functionally within the organization.
- Demonstrated initiative and ability to work independently while handling multiple tasks.
- Strong decision-making and prioritization skills.
- Strong written, verbal, and interpersonal communication skills.
- Strong organizational and presentation skills.
Qualifications/ Background Experiences
- Position requires a 4-year degree in engineering or a scientific discipline or equivalent work experience.
- Minimum 2 years’ experience in a Quality Engineering, Compliance, or other related Quality System role(s) in a medical device or pharmaceutical company
- Experience with electronic quality system tools (eQMS/eDMS).
- Experience with Change Management, Computer System Validation
- Six Sigma certification a plus
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 $80,000 - $110,660