|職務内容||〇 Coordinating, execution, monitoring, maintenance and improve g QMS processes to streamline and ensure compliance. Identify key process indicators, analyze and report relevant metrics for these processes to management.
〇 Designated process owner/subject matter expert, Management Review, monitoring and exporting business KPIs and metrics, Division Policy alignment. Performing trend analysis of quality metrics across quality data sources specific to the above quality processes.
〇 Translate AQR quality objectives into concrete strategic and tactical plans with clear milestones and accountable governance, including metrics.
〇 Works across all functional roles in the business, including Quality, Operations, Engineering to identify ways to streamline quality process and owns implementation of those improvements.
〇 Builds consensus across functions, driven from data, metrics and measures of the quality processes, and makes recommendations directly to leadership where the improvement measures will affect multiple functional areas.
〇 Leads quarterly Management Reviews reporting on implementation status and performance of the Quality Framework and systems.
〇 Ensures KPI reporting on key quality data measures, and works collaboratively in defining metrics and uses these data to establish focus areas for continuous process improvements.
〇 Monitor external and internal inspectional results, assessing performance trends, sharing relevant information across the business and supporting entities in defining appropriate corrective actions.
〇 Builds plans to implement process improvements and periodically assesses business compliance with AQR policies and procedures. Owns development of resource-efficient implementation plans, aligns priorities and objectives with remediation, and other division-wide programs.
〇 Administers the electronic Document Management System(s) and Change Management process to ensure efficient organization, review, approval & delivery of documents, training of all users, implementation and validation of new system or upgrades to existing system, and compliance with all applicable standards. Writes, reviews and approves Quality System documents as necessary.
〇 Administers the electronic training program to ensure adequate quality/regulatory training of all personnel. Establish and deliver training programs for Quality processes within the business Quality Management system, where required, including assisting in defining training plans to improve QS awareness in commercial and other functions. Works with management to define & document required quality training as part of the overall training program.
〇 Supports quality management by participating in other quality system processes, including Quality Planning, Management Review, Audits, complaints and non-conformance. Acts as the Quality representative on cross-department and/or site teams, such as product development and design control.
〇 Actively participates in or facilitate audit and self-assess routine maintenance of ISO 13485 cGMP requirements. Organizes and facilitate external (notify body/health authority) audits support.
〇 Apply established quality and engineering methods to the investigation of product and process failure. Provide technical expertise in root cause analysis and statistical techniques to identify solutions to a range of problems. Performs CAPA (Corrective Action Preventive Action) and FCA (Field Corrective Action).
〇 Investigates and analyzes impact of product and process failure. Use technical, compliance, product and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent reoccurrence.
〇 Demonstrate awareness of changes in the quality and regulatory environment. Utilize good judgment and make timely decisions which consider the facts and data at hand.
Champions specific projects, knowing when to escalate to management.
〇 Understand and assess the impact of a change on the safety and efficacy of in-vitro diagnostic medical device product, process performance.
〇 Lead Risk Management activities. Assess internal and external risks associated with specific actions, quantify risks, seek input from others, and takes actions to limit the exposure to the business.
|応募資格||〇 Minimum 8 year BS degree in in Science or Engineering or technical discipline, advanced degree (MS/PhD) preferred
〇 6 plus years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
〇 Working experience of FDA’s 21 CFR Part 820 Quality System Regulation, ISO 13485:2016 Medical Devices, and ISO 14971:2012 Risk Management.
〇 Working experience of regulations relating to in-vitro diagnostic medical device products, Knowledge of regulatory submissions process.
〇 Working knowledge and experience complaints, CAPA and root cause analysis.
〇 Extrapolate meaningful and defensible conclusions from limited data using analytical methodologies, integrate complex data and identifies critical process variables.
〇 Demonstrates project management skills
〇 Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise.
〇 Flexibility to adapt to changing assignments and ability to effectively prioritize.
〇 Excellent written and verbal communication skills. fluent Japanese and English reading, writing and speaking ability.