Spec QA DMR

Job Summary

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 ISO
13458 and CFR
820.

• Collect and review Device Master Record (DMR) documents for Medline products subject to the regulatory requirements and project development plan.
• Establish inspection criteria of new finished products, update and maintain inspection criteria for existing products on Medline quality management platform (ETQ).
• Maintain functions of inspection criteria in Medline quality management platform (ETQ) available for inspection.
• Provide training to internal and external stakeholders on the procedure and requirement of DMR and inspection criteria when necessary.
• Conduct change control by reviewing documents provided by suppliers who have submitted the requests, and assist in helping suppliers complete the changes.
• Conduct sample construction review for new products, and assist in helping suppliers understand the product specification.
• Complete monthly Complaint Trending Report and make adjustment as requirement of DQA if some improvement is needed.
• Complete Supplier Re‑Evaluation by reviewing suppliers who have already been processed through the Vendor Evaluation Procedure and their approximate three‑year review is approaching and providing corresponding dispositions.
• Review the Component Sourcing Form completed by suppliers and assign Quality Warnings (QW Codes) based on the suppliers’ review results.
• Implement the improvement plan and standardize the processes if necessary and share good experience with team members.
• Other projects assigned by managers/DQAs.

• Education level:
  Bachelor degree at least.
• Working experience: 3-5 years working experience, at least 2 years’ experience on quality control or supplier quality management.
• Understanding 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 ISO
  13485 or IS09001 is a plus.
• Certifications:
  
  CET-6.
• Language: excellent verbal and written English.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.