Senior QA Specialist

JOB SUMMARY: Provide a brief summary of the overall purpose of the role within the organization.

Sr. QA Specialist is responsible for quality assurance on the procedures of DMR and inspection criteria development and maintenance. Work closely with divisional QA and Asia stakeholders to ensure requirements are met under ISO13458 and CFR820 and continuously improvement on process.

CORE JOB RESPONSIBILITIES: List the primary/essential job duties and responsibilities & the objectives of the role.

1. Collect and review Device Master Record (DMR) documents for Medline products subject to the regulatory requirements and project development plan;

2. Establish inspection criteria of new finished products, update and maintain inspection criteria for existing products on Medline quality management platform (ETQ);

3. Maintain functions of inspection criteria in Medline quality management platform (ETQ) available for inspection;

4. Provide trainings to internal and external stakeholders on the procedure and requirement of DMR and inspection criteria when necessary;

5. Conduct change control by reviewing documents provided by suppliers who have submitted the requests, and assist in helping suppliers complete the chang;

6. Conduct sample construction review for new products, and assist in helping suppliers understand the product specifications;

7. Complete monthly Complaint Trending Report, and make adjustment as requirement of DQA if some improvement needed;

8. Complete Supplier Re-Evaluation by reviewing suppliers who have already been nprocessed through the Vendor Evaluation Procedure and their approximate three-year review is approaching and providing corresponding dispositions;

9. Review the Component Sourcing Form completed by suppliers, and assign Quality Warnings (QW Codes) based on the suppliers’ review results;

10. Lead continuous process improvement, Kaizen, problem-solving related to the team;

11. Back-up of quality supervisor/manager.

BASIC Technical Skills: List essential abilities in practical & technical knowledge which are required to perform the job.

• Have deep understanding or experience on quality inspection process and the logic of inspection criteria creation;

• Great knowledge on inspection techniques such as ANSI/ASQ Z1.4;

• Great knowledge on inspection tools such as sampling rulers and gauges;

• Excellent communication and coordination skills;

• Proficient skill in Office software;

• Strong project and time management skills.

Qualification: please state the minimum & necessary qualification required to successfully perform the job.

• Education level: Bachelor degree at least;

• Working experience: 3-5 years working experience, at least 3 years’ experience on quality control or supplier quality management;

• Understanding or experience on supplier manufacturing process and inspection process;

• Knowledge on regulation/standards, risk assessment, customer needs, historical adverse events, etc. with inspection criteria;

• Specific knowledge: Quality system knowledge of ISO13485 or IS09001 is a plus;

• Language: excellent verbal and written English.

Additional: Please state the preferred but not essential requirements

(1) Experience in project management or supplier quality management;

(2) Quality assurance work experience on medical device industry;

(3) (3) Be able to travel about 10%.