|部署・役職名||Quality Engineer （inc. Senior）|
This position is a Quality Engineer role within the Rapid Diagnostics Business Unit.
Although Work From Home is and will be allowed, it will be advised that you work closely with your R＆D － at least at the beginning － in the plant located in the East part of Chiba.
Reporting to the Global QA Engineering Manager, you will 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 t
Your goal will be to ensure that R＆D teams have thought about the appropriate design inputs and outputs, risk assessments, materials selection, Intended use and product Specification.
What makes this role particuarly interesting is that you will be given the opportunity to lead a team after proving your credibility.
【必須（MUST）】－ 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
－ 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.
－ 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）
－ Ability to work independently and be self－motivated
－ Flexibility to adapt to changing assignments and ability to effectively prioritize.