|職務内容||Work with R&D team throughout product development until the production implementation. Provides technical and quality system guidance related to establishing
〇 Supports verification and validation activities for new products in accordance with design planning procedures. 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 Directly influences project direction and scope, guides product development teams through design validation and regulatory compliance and assures robust product vs. customer requirements.
〇 Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
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 design plans, product design and deliverables related to product software are met. Represent the quality engineering function for the
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 Reviews and assesses activities (suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards and regulatory requirements.
〇 Supports 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.
〇 Investigates and analyzes impact of failure within and across product lines. Uses technical, compliance, product and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent reoccurrence.
〇 Works as an individual contributor and may provide guidance or oversee work of other quality engineer team members.
|応募資格||【BASIC QUALIFICATIONS | EDUCATION】
〇 Minimum 4 year BS degree in a scientific or technical discipline, advanced degree (MS/PhD) preferred or 12+ years of experience in a related field. 10 plus years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes. Previous quality engineering experience and demonstrated use of quality tools/methodologies
〇 Or Mechanical Engineer, 8+ years of experience in Medical Device New Product Development, DHF Remediation. Expertise in all phases of Systems Development in an IVD environment
〇 Knowledge of regulations and standards affecting software development and overall design control for medical devices.
〇 Knowledge / experience on medical device design controls / DHF remediation and MQMS process (e.g. 21CFR 820, ISO 13485, ISO 14971, IVDD, IVDR and able to understand system level interactions as well as working knowledge of current and applicable GMP regulations is required
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 Advanced understanding of compliance, cGMP, development and validation. Able to relate information to product specifications product claims and design.
〇 Able to prepare, analyze and present Key Performance Indicators (KPIs).
〇 Experience with root cause analysis, design control, design transfer, Risk Management, and validation activities.
〇 Process Excellence certified (Green Belt / Black belt).
〇 Analytical/Problem Solving Skills (e.g. DMAIC, statistical techniques, risk analysis)
〇 Excellent written and oral communication skills with ability to interact with all levels leader-ship, internal/external customers and third-party vendors.
〇 Ability to work independently and be self-motivated