Overview

Role: Senior Quality Engineer Medical Devices (Design Quality & Compliance)Location: Cincinnati BMC, OHNumber of Positions: 3Role Description:Must Have Technical/Functional SkillsKnowledge of Quality Management Systems and applicable quality tools and techniquesKnowledge of GMP, FDA Quality System requirements, ISO 13485 and applicable compliance regulationsKnowledge of medical device regulatory standards, including design control and risk management requirementsKnowledge of NC, CAPA, deviation, Root Cause Analysis, change control and audit processesKnowledge of statistics, Risk Management, Design Control and process validationExperience creating and reviewing DFMEA, PFMEA, risk management records, protocols and technical reportsExperience with verification and validation documentation and IQ/OQ/PQ activitiesExperience with Post Market Surveillance and quality trend evaluationExperience with PLM/eQMS tools; Windchill experience is preferredGood understanding of engineering drawings, specifications, tolerances and GD&TExperience supporting neurovascular, catheter-based, implantable or other Class II/Class III medical devices ispreferred Strong written and verbal communication, problem-solving, planning and project-management skills Proficiency with word processing, presentation, e-mail and spreadsheet software Ability to manage multiple priorities, meet timelines and communicate project status clearly Experience preparing and maintaining Quality Plans Experience supporting technical transfer (tech transfer) and manufacturing transfer activities Experience providing QMS support, including internal/external audit and CAPA support Experience writing and revising Quality SOPs and Work Instructions (WIs)Roles & ResponsibilitiesUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations andCorporate Johnson & Johnson procedures and guidelines, the duties and responsibilities for this position are:Provide quality engineering support for Cerenovus neurovascular products throughout product development,design changes, technical transfer (tech transfer), manufacturing transfer and sustaining activitiesPrepare, develop, review, maintain and approve Quality Plans and Product Development Process deliverables,including protocols, reports, specifications and engineering documentationReview and approve R&D/Engineering verification and validation protocols and reportsDevelop and maintain risk management records, including DFMEA and PFMEA, in collaboration with subjectmatter expertsSupport and provide quality guidance for process validation and equipment qualification activities, including IQ,OQ and PQProvide Quality Management System (QMS) support and maintain Quality documentation to ensure objectiveevidence is complete, accurate and traceableLead or support audits, Root Cause Investigations and closure of nonconformances, deviations and CAPAs;support audit responses and verify effectiveness of implemented corrective and preventive actionsReview and approve Change Orders, including CR/CN documentation, and assess product, process, qualityand regulatory impactApply statistical methods to process and product data, including capability analysis, sampling rationale andmeasurement system assessment, as applicableSupport post-market quality activities, complaint trending and design or process enhancementsWrite, review, revise and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs) forQuality functionsInterpret new or upcoming quality and regulatory requirements and provide guidance to cross-functional teamsPartner with R&D, Manufacturing, Regulatory, Operations, Supplier Quality and other internal teams to createand approve deliverablesPerform other duties assigned as neededGeneric Managerial Skills, If any Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language. Ability to multitask, including ability to understand custome