- Save Job
- Email Job
- QA&RA combined position.
- Possibility of cooperating with other quality related areas.
About Our Client
Our client brings together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases. Headquartered in the US, our long standing history client have provided excellent solutions taking care of the people health.
Job Description
* Coordinate QMS processes to streamline and ensure compliance. Identify key process indicators, analyze and report relevant metrics for these processes to management leaders.
* 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.
* Translate quality objectives into concrete strategic and tactical plans with clear milestones and accountable governance, including metrics.
* 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.
* 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.
The Successful Applicant
* 3 plus years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
* Working experience of ISO 13485:2016 Medical Devices, and ISO 14971:2019 Risk Management.
* Working knowledge and experience complaints, CAPA and root cause analysis.
* Extrapolate meaningful and defensible conclusions from limited data using analytic methodologies, integrate complex data and identifies critical process variables.
* Demonstrates project management skills.
* Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise.
* Excellent written and verbal communication skills. Fluent Japanese and English reading, writing and speaking ability.
What's on Offer
* Possibility to work in an environment that cherish diversity.
* Attractive salary package.
Job summary
- Function
- Engineering & Manufacturing
- Specialisation
- Quality, Technical
- What is your area of specialisation?
- Healthcare / Pharmaceutical
- Location
- Chiba
- Job Type
- Permanent
- Consultant name
- Eduardo Takara
- Consultant phone
- +813 6832 8678
- Job Reference
- JN-112021-4526405
- Company Type
- Foreign Multinational