Terumo Medical in Elkton, MD is hiring for a Senior New Product Development Quality Engineer! This position is open to support the acquisition of a revolutionary new product. This candidate must have experience with combination devices. No better time than today to join a growing organization that prides itself on quality and it's continuation of contributing to society through healthcare. Job : The Senior NPD Quality Engineer 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 Senior NPD QE 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 Senior NPD QE 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: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 projects of all levels of complexity with no guidance required. 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. : BS or Advanced Degree (MS) in Systems, Mechanical, Biomedical, or similar engineering discipline with increasing responsibility in Product Development and Systems Engineering preferably within the Medical Device industry. 3+ years of industry experience POSITION REQUIREMENTS: Requires a minimum of a 4 year degree in engineering, life sciences, or similar. Candidates must have combination medical device experience Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and manufacturing. 4-6 years of direct experience in a Product Development or R&D Organization Requires six to ten years increasing responsibility and experience in a medical device quality assurance environment. Prefer one to two years of auditor experience. Strong communication skills both verbal and written. 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 Prefer certification as a CQA, CQE, or CQM, and member of the ASQ. Prefer Six Sigma certification. 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. Terumo is an equal opportunity employer.