Our client is a joint venture of US medical equipment manufacturer and a major Japanese pharmaceutical company.
Reports to: Quality Assurance Senior Director
Department: QC Department
- 3PL warehouse, product introduction, quality-related issues from product receipt to delivery.
- Thorough compliance with quality assurance contracts related to 3PL warehouse and service center, Bard warehouse and service
- Corporate, company, and law and standard requirements and to maintain
- Maintain QC department's and ISO documents.
- Implement improvements on a continuous basis.
- To solve quality problems of accepted products, quality problems in 3PL warehouse, quality problems related to domestic product shipment.
- Verify implementation of the solution to the above quality problem and take necessary action to prevent the recurrence of the problem.
- Continue to maintain compliance in cooperation with each person in charge.
- Develop and implement education and training programs for employees as necessary.
- Deviated from requirement criteria
- Ensure that batch documents are being reviewed. If there is no problem, approve the release of the product.
- Ensure that all manufacturing-related deliverables are subject to specified quality requirements. In addition, it is influenced by consolidated information
- And planning and reviewing test items and advising methods and equipment used for testing and inspection
- Science Background
- Work experience with regulatory authorities (PMDA, ISO certification body, etc.)
- ISO 13485 standard and all related regulations, standards
- Various oral and written communications, presentation skills, customer-oriented attitudes, professionalism
- Business travel - for training seminars (5-10 days/year)
- English ability
- supplier audit, quality management system
The company is one of the world's largest providers for products and support instruments for the medical industry.