Quality Compliance Engineer II

Company: Terumo Corporation
Location: Somerset
Posted on: February 25, 2021

Job Description:

Job Summary:The Quality Compliance Engineer II is responsible for maintaining the compliance of TMCs products and processes in the changing regulatory landscape.--Specifically, the individual will be responsible for managing EUDAMED, Health Hazard Evaluations, tracking of EU MDR deliverables, supporting cross-functional project team with compliance related decisions/interpretations, and evaluating impact of standard/regulation updates to existing product families. Job Details: - Support standards/regulation program by leading the evaluation of new and revised standards/regulations for impact to products- Manage interaction with EUDAMED for ongoing compliance to EU Medical Device Regulation.--Be responsible for reporting all required reports to the European authorities through EUDAMED.--This includes leading the EU MDR Governance Board to track/manage Annual EU MDR product deliverables (Risk, PMS&V, Clinical, etc---) - Oversee and execute TMC health hazard and recall process. - Coordinate the HHE process by engaging the stakeholders (ex: Medical, PMS) to ensure the HHE is completed in a timely manner.- Support the drafting, planning, execution, and gathering of information for the Critical Action Committee meeting.- Execute the recall process by drafting regulatory submission documents, coordinating reviews of recall documentation, working with affiliates and recall service providers to execute the recall. - Support cross-functional projects (New Product Development, Sustaining, Acquisition, etc---) as a compliance SME - Act as independent reviewer on design control projects to ensure compliance with internal procedures and external standards and regulations.i. Perform Design Assurance reviews for New Product Development and significant design change projects.ii. Provide quality system and product guidance on updated regulations/standards.9.Maintain expertise in quality management standards, software and tools applicable to Terumo Medical Corporation10.Good documentation practices, ISO 13485, GDP, validation and verification/qualification.11.Develop and maintain expertise in applicable quality regulations, including, but not limited to: U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) for Medical Devices (21 CFR 820).Health Canada cGMP, European MDD and MDR12.Provide ongoing reinforcement of compliance and quality culture.13.Drive Quality System or product enhancement projects associated with regulatory changes. 14.Review and draft proposals to implement changes to the Quality System procedures/forms as needed to maintain compliance, improve effectiveness and efficiency.15.Assist and/or conduct internal audits to assess compliance with applicable regulations and standards (e.g. - Quality System Regulation (QSR), ISO 13485, ISO 14971, ISO 11607, ISO 11135/ EN550, ISO 11137/ EN552 and the amended Medical Device Directive).16.Assist with third party/regulatory audits (Customer, Notified Body, FDA) 17.Performs other job related duties as assigned.Position Requirements: Quality and business process knowledge:o Familiarity with FDA, ISO 13485, EU MDR and multi-country Quality Systems requirements.o Ability to identify and recognize how the standards & regulations potentially affects the wider business of the companyo Ability to use process development tools (ex. Lean Six Sigma)o Ability to apply a practical level of statistics.--Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs and user-friendly reportsLeadership skills:o Demonstrated ability to communicate and interact with all levels of the organization including managemento Strong interpersonal skills to provide coaching, training, and direction Individual skills required:o Strong proofreading and writing skills, as well as exemplary attention to detailo Strong organizational and prioritization skills * Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.* Technical knowledge to be able to summarize and distill complex information.* Demonstrated initiative and ability to work independently while handling multiple tasks* Strong computer knowledge (MS Office), technical writing skills and proofreading ability* Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.Background Experiences:B.S. degree or equivalent in Engineer or Scientific discipline required.3-5 years' overall experience required with at least 3 years of related experience in Medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on product or production or quality-related responsibilities preferred

Keywords: Terumo Corporation, Trenton , Quality Compliance Engineer II, Engineering , Somerset, New Jersey