NPD Quality Engineer II

　　Date: Feb 6, 2024

　　Req ID: 2756

　　Location:

　　Elkton, MD, US

　　Company: Terumo Medical Corporation

　　Department: TIS Design Assurance/Quality Engineering

　　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 $5+ billion in sales, 20,000+ 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.

　　Job Summary

　　The NPD Quality Engineer II will plan, coordinate, and manage the quality assurance (QA) activities associated with one or multiple New Product Development (NPD) projects to ensure compliance to internal and external requirements during the development and commercialization of new products. This individual will provide QA leadership and partner with the NPD organization in efficient, effective and rapid development and commercialization of new products. This individual will manage the effective oversight of NPD QA activities, as well as participate as an active QA representative on project teams. The NPD QE II manages the daily operation of the NPD quality aspects of one or multiple projects by ensuring timely completion of NPD Quality Assurance deliverables that meet the company standards for quality. This individual provides NPD teams with clear, consistent and timely feedback as it relates to compliance exposure and will provide innovative solutions to effectively resolve investigations and to meet the needs of customers, regulatory bodies and Terumo business requirements.

　　As part of a project team, the NPD QE II will be responsible for developing sound Design History File deliverables, including, but not limited to, Quality Plans, Supplier Qualification Strategies/Quality Agreements, Manufacturing Quality Plan, Design Verification protocols and reports, and conducting Design History File Verifications at the end of each design control phase. In addition, the Principal, NPD QE will actively participate in design characterization, risk management activities, and design and process validation.

　　Job Details/Responsibilities

　　Represent Quality on product development teams to ensure adherence to company quality procedures and applicable US and OUS regulatory requirements and standards.

　　Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned project activities

　　Lead quality system development and implementation throughout product life cycle

　　Provide oversight for internal and external metrology, incoming inspection, acceptance criteria, disposition of non-conforming materials, and measurement system evaluations.

　　Assure that all applicable elements and product technical standards that are applicable to a design category are effectively incorporated into new designs and into changes to designs.

　　Review and approve/reject technical transfer plans and reports from the design transfer perspective. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested

　　Lead teams and ensure completion of Risk Management activities for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.

　　Leads cross functional team on how to documents changes, using a risk based approach for determining requirements.

　　Lead master validation planning sessions for assigned projects.

　　Job Responsibilities (continued)

　　Addresses defect prevention through review of quality history, supplier base controls, scrap analysis, process control techniques and training.

　　Acts as the Technical Specialist to Purchasing in supplier-related quality issues.

　　Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products

　　Participate in supplier selection process and component specification reviews to ensure that purchased items meet specifications

　　Develop and validate quality test methods.

　　Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

　　Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

　　Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

　　Review and approve product and process qualification and validation and other change control related documentation.

　　Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.

　　Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.

　　Performs analytical measurements and experiments to qualify or resolve product and process issues.

　　Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.

　　Monitor field quality and analyze field returns to determine root cause.

　　Provide training and support for quality system processes and quality engineering practices.

　　Internal contacts: All departments, including manufacturing, engineering, marketing/sales.

　　External contacts: Customers and vendor contacts regarding purchases and services.

　　Knowledge, Skills and Abilities (KSA)

　　Strong communication skills both verbal and written.

　　Strong organizational skills as well as time management skills essential for project work.

　　Self motivating and able to balance multiple priorities and tight deadlines with minimal supervision

　　Experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is required.

　　Excellent computer skills

　　Strong writing, mathematics and statistics skills

　　Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.

　　Qualifications/ Background Experiences

　　Requires a minimum of a 4 year degree in engineering, life sciences, or similar.

　　Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and manufacturing.

　　2-5 years direct experience in a Product Development or R&D Organization

　　Requires 3 to 6 years increasing responsibility and experience in a medical device quality assurance environment.

　　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.