Thông tin công việc
Mô tả
QMS Management:
1. Create/Update work instructions, inspection checklists, procedures, and related medical device regulation as needed.
2. Participating in internal and external audits, manage non-conformance reporting, investigations, and complaints
3. Effective corrective/preventative actions and follow-up for internal and external quality issues
4. Develops control and inspection plans for internal manufacturing, incoming materials, and components
5. ISO 13485 and FDA 21 CFR 820 Support
6. Undertake additional responsibilities or activities as required by their supervisor
Quality Assurance Management:
1. To ensure alignment with departmental activities and organizational direction and goals.
2. Assesses the understanding of Quality Systems and Continuous Improvement within the Quality Teams
3. Develops and delivers training to the Quality team members from the Quality Control mindset
4. Closely works with the production department to communicate accurate results and root causes identified through the quality review for continuous problem-solving initiatives.
5. Establishes qualitative and quantitative performance standards of work performed and ensures standards are being implemented
6. Responds to complaints, inquire and audit-related questions from relevant third parties
7. Develops and implements program plans including resource requirements, new program ideas, best practice protocols.
Yêu cầu
Attitudes:
Careful, enthusiastic, dynamic, hard-working to learn
Easy to work in a high-pressure environment
Have a high sense of responsibility and teamwork
Have a long-term orientation and self-development at the company
Skills:
Time management skills
Job management skills
Leadership skills
Operation planning skills
Skills of identifying, analyzing and, solving problems
Good communication and interaction skills
Skills to build and develop workflow
Knowledge:
Must be familiar with ISO 13485; and FDA Audit
Train and lead the employees to make the right process
Knowledge about medical products
Two or three years of experience in the same position
English (Good at 4 skills)
Advanced in Microsoft Office (Word, Excel, PowerPoint)
* Certified Dental Technician (CDT) certification is a plus
Note: Only select candidates who can be self-sufficient in transportation
- Bằng cấp:
Đại học - Thời gian thử việc: 2 months
- Độ tuổi:
Không giới hạn tuổi