|部署・役職名||IVD Design Engineer Manager【試薬・診断薬】|
The position of Quality Engineer is within our IDEM Business Unit located at our Chiba
Plant, in Japan.
This role to assure the quality of the design process and the ultimate robustness of the
new product design and will be responsible to work with the R＆D teams throughout the
design ＆ development process from concept through design freeze to ensure that R＆D
teams have thought about the appropriate design inputs and outputs, risk assessments,
materials selection, Intended use and product Specification. In addition, this role is a
key team member at Design Reviews, Stage Gate Reviews, Design Freeze and Design
Transfer and they both review and approve all Design documents including Design
Verification ＆ Validation protocols/reports as well as Clinical Study Protocols and/or
This job function has accountability for complying with the applicable elements of
Global Quality and the ARDx Quality Management System （QMS）.
This job description will be reviewed periodically and is subject to change by
• Work with R＆D team throughout product development until the production implementation. Provides technical and quality system guidance related to establishing
• 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.
• Directly influences project direction and scope, guides product development teams through design validation and regulatory compliance and assures robust product vs.
• Leads meetings to prioritize, review and/or approve of action plans for addressing issues
captured in problem resolution systems during development.
• 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..
• Performs risk evaluation and associated management activities related to development
including FMEA, product risk analysis, and mitigation of issues.
• 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
• Understands and assesses the impact of a change on the safety and efficacy of IVD product,
process performance, and internal/external customer expectations worldwide.
• 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.
• Reviews and assesses activities （suppler evaluations, validation, lifecycle deliverable documents） to ensure compliance with applicable procedures, standards and regulatory
• Supports validation by assessing the need for validation and preparing and/or supporting
protocols, reports and other documentation as required.
• Develops local strategy in alignment with the business goals and implements related
tactical activities. Translates strategic needs into executable plans.
• 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.
• Works as an individual contributor and may provide guidance or oversee work of other
quality engineer team members.
【必須（MUST）】BASIC QUALIFICATIONS | EDUCATION:
• 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
• 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
• Knowledge of regulations and standards affecting software development and overall design control for medical devices.
• 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
• Strong analytical skills, ability to organize work in a logical and thorough manner.
• Able of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues.
• Demonstrate problem－solving skills. Identify and resolve problems in a timely manner.
• Work collaboratively in group problem solving situations, risk assessment.
• Ability to read / understanding, engineering drawings and Interpret the
operation/functions of the component.
• Good understanding CAD tool, Solid works 2018.
• Extrapolate meaningful and defensible conclusions from limited data using analytical
methodologies, integrate complex data and identifies critical process variables.
• Highlights issues in a timely manner and presents possible resolutions. Seeks additional
information when problem is beyond area of personal expertise.
• Works closely with external and internal design teams to understand and resolve product performance issues.
• Ability to work independently and be self－motivated
• Flexibility to adapt to changing assignments and ability to effectively prioritize.
• Advanced understanding of compliance, cGMP, development and validation. Able to relate information to product specifications product claims and design.
• Able to prepare, analyze and present Key Performance Indicators （KPIs）.
• Experience with root cause analysis, design control, design transfer, Risk Management,
and validation activities.
• Process Excellence certified （Green Belt / Black belt）.
• Analytical/Problem Solving Skills （e.g. DMAIC, statistical techniques, risk analysis）
• Excellent written and oral communication skills with ability to interact with all levels
leader－ship, internal/external customers and third－party vendors.
• Experience in rapid diagnostics industry
• Works in a collaborative, fast－paced, goal－driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences. Removes barriers
that block goal attainment
• Able to work independently and report efforts. Takes personal responsibility to resolve
• Demonstrates accountability for complying with local and global Quality System
• Helps drive and promote understanding of the need for change through the organization.
• Influence outcomes appropriately, influences others to support a course of action,
influences activities without reliance on formal authority
• Provide mentoring in quality, compliance, and technical areas across multiple work
groups. Provides constructive and timely feedback to ensure compliance and mitigate
• Strong communication skills – Japanese and English in written and verbal; briefing,
presentation, education/training skills.
• Define objectives and priorities, establish milestones, anticipate and mitigate risks, lead
team member to goal while maintaining strong attention to detail.
• Demonstrates project management skills.
• Excellent communications skills with ability to write technical and quality documents in a clear and structured manner, （procedures, verification plans , reports）
• Demonstrating flexibility and ability to provide leadership under pressure whilst dealing with ambiguity in a fast－changing environment.