Assoc Spec QA DMR

About the role

Associate QA specialist is responsible for quality assurance on the procedures of DMR and inspection criteria data maintenance. Implement the actions under supervisor's supervision to ensure requirements are met under ISO13458 and CFR820.

Responsibilities

• Assist in collecting and verifying Device Master Record (DMR) documents for Medline products in compliance with regulatory requirements and project schedules;
• Support drafting inspection criteria for new finished goods, assist in updating and maintaining criteria for existing products on Medline quality management platform (ETQ);
• Help keep all inspection criteria on Medline quality management platform (ETQ) fully functional for daily inspection use;
• Support document review for supplier change control requests and assist supplier in finishing relevant change procedures;
• Participate in new product sample build review and assist supplier in understanding product specifications;
• Prepare monthly Complaint Trending Report; adjust report contents per DQA's improvement requests;
• Assist with supplier re-evaluation for vendors due for their periodic review under Vendor Evaluation Procedure and issue corresponding review dispositions;
• Review Component Sourcing Form submitted by suppliers and assign Quality Warnings (QW Codes) based on review outcomes;
• Collect the COC/COA from suppliers, conduct verification and upload records to the quality system;
• Complete ad-hoc tasks and special projects assigned by supervisors and DQA team.

Qualifications

• Bachelor degree at least;
• 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;
• Quality system knowledge of ISO13485 or ISO9001 is a plus;
• CET-6 certification;
• Excellent verbal and written English.

Benefits

• Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average;
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.