Product Quality Assurance Manager
|職務内容||Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
The position of Production Quality Assurance is within our IDEM Business Unit located at our Chiba Plant, in Japan.
This role to assure the quality of the production as well as the process and the ultimate adequateness of calibration, validation, MAXIMO system etc. to rolling-out and will work closely with engineers on the Production team to progress the Collaboration strategy and meet availability and security requirements, and defined QMS also AQR requirements. The position requires an ability to deeply understand the complexities of the relevant production and/or Lab equipment/instrument/facility and must possess strong GMP knowledge with the ability to ensure the production quality. Strong verbal and written communication skills are required.
This job function has accountability for complying with the applicable elements of Global Quality and the ARDx Quality Management System (QMS).
〇 Work with Production engineer (maintenance & improvement) team to carries out duties in compliance with established business policies and procedures. Provides technical and quality system guidance related to establishing relevant requirements.
〇 Supports verification and validation activities for production processes in accordance with QMS/AQR requirements. This includes, but is not limited to, review and approval of protocols and reports, review of development plans, and review of other system and documentation.
〇 Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems.
〇 Applies established quality and engineering methods to the investigation and solution of quality problems. Provides technical expertise in root cause analysis and statistical techniques to identify solutions to a range of problems..
〇 Performs risk evaluation and associated management activities related to development including FMEA, product risk analysis, and mitigation of issues.
〇 Participates in technical and management reviews to ensure validation plans, calibration plan, or else production related quality are met.
〇 Understands and assesses the impact of a change on the safety and efficacy of IVD product, process performance, and internal/external customer expectations worldwide.
〇 Defines the business results expected from risk management strategies and projects. Assesses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and takes actions to limit the exposure of the division.
〇 Performs validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
〇 Develops local strategy in alignment with the business goals and implements related tactical activities. Translates strategic needs into executable plans.
|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 Strong analytical skills, ability to organize work in a logical and thorough manner.
〇 Able of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues.
〇 Demonstrate problem-solving skills. Identify and resolve problems in a timely manner.
〇 Work collaboratively in group problem solving situations, risk assessment.
〇 Ability to read / understanding, engineering drawings and Interpret the operation/functions of the component.
〇 Extrapolate meaningful and defensible conclusions from limited data using analytical methodologies, integrate complex data and identifies critical process variables.
〇 Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise. • Excellent communications skills with ability to write technical and quality documents in a clear and structured manner, (procedures, verification plans , reports)
〇 Ability to work independently and be self-motivated
〇 Flexibility to adapt to changing assignments and ability to effectively prioritize.