Quality Assurance Coordinator (Medical Devices)
Location: St. Louis, MO (Onsite)
Job Type: Direct Hire, Full-Time
Schedule: Monday–Friday, 8:00 a.m. – 4:30 p.m.
Salary: $60,000–$70,000 per year
Our client, a leading medical device manufacturer, is seeking a Quality Assurance Coordinator to support the Director of Quality and help maintain compliance with industry and regulatory standards. This role is critical to ensuring the effectiveness of the Quality Management System (QMS) and supporting product quality that directly impacts patient safety.
Key Responsibilities
• Maintain and improve QMS document control systems to ensure accuracy and audit readiness.
• Coordinate review, approval, and distribution of controlled documents.
• Ensure procedures and records comply with ISO 9001 and ISO 13485 standards.
• Own CAPA tracking, ensuring timely progress from initiation through closure.
• Monitor investigation timelines and follow-up with cross-functional teams on deliverables.
• Escalate overdue quality activities to management as needed.
• Log and manage customer complaints, product returns, and feedback.
• Route issues to appropriate engineering or quality teams and track through resolution.
• Compile and analyze monthly quality metrics, identifying trends and areas for improvement.
• Maintain organized and accessible quality records.
Qualifications
• Bachelor’s degree or equivalent technical experience.
• 2+ years of experience in Quality Assurance, preferably in a regulated industry.
• Working knowledge of ISO 9001; ISO 13485 experience strongly preferred.
• Proficiency in Microsoft Office (Word, Excel, Outlook).
• Strong organizational, communication, and time management skills.
• Ability to manage multiple priorities and meet deadlines.
• High attention to detail and ability to work independently.
Work Environment
• Onsite role based in St. Louis, MO
• Collaborative, cross-functional team environment
Benefits
• Competitive salary
• Health, dental, and vision insurance
• Paid time off and holidays
• 401(k) with company match
Work Environment/Physical Demands
• Must have ability to read, write and communicate fluent English; ability to compose documents in the appropriate business style using correct grammar and spelling; ability to communicate clearly using proper grammar
• Ability to work overtime as needed
• The physical demands regularly require the employee to use hands, arms, and fingers to handle/operate tools and equipment; to walk, sit, climb, balance and crouch. Employee must be able to frequently lift up to 50 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
