Quality Assurance Coordinator

Job Title:
Quality Assurance Coordinator

Location
:
Woodinville - Bothell

Shift & Hours
:
Monday-Thursday: 5:00 AM - 2:30 PM

Friday: 5:00 AM - 9:00 AM

• Ensure product quality by performing incoming and final inspections, maintaining quality records, and supporting continuous improvement initiatives.
• Work under limited supervision to uphold compliance with regulatory standards and company policies.

• Perform incoming and final release inspections of purchased finished goods in the warehouse.
• Create inspection plans and update work instructions.
• Conduct Test Method Validation (TMV) assessments and inspection planning creation.
• Generate Non-Conforming Material (NCM) records for failed inspections.
• Maintain quality system documentation (DHR, inspection, and related records).
• Collaborate with warehouse operations and supplier quality (SQ) teams to resolve quality issues.
• Manage daily management boards, track metrics, and report departmental performance.
• Support lean initiatives and continuous improvement projects.
• Prepare and report departmental KPIs to management.
• Escalate quality or operational issues to direct manager.
• Team-oriented and detail-focused mindset.
• Strong problem-solving and decision‑making skills.
• Ability to handle multiple tasks efficiently.
• Effective communication and organizational skills.
• Self‑motivated with accountability and urgency to deliver results.
• Commitment to operational excellence and continuous improvement.

• 3 years of experience in the medical device industry (preferred).
• Prior work in manufacturing or warehouse environments required.
• Experience with CMM and measuring equipment.
• Knowledge of TMV, First Article Inspection, and SAP (MRP/ERP) systems.
• Understanding of CAPA, 21 CFR Parts 803, 806, 820, ISO 13485, and EU MDR standards.
• Ability to read and interpret engineering drawings and tolerances.

• Minimum:
  High School Diploma or Vocational Education
• Preferred:
  Additional certifications in Quality, Inspection, or related fields

• Quality Assurance (QA) & Quality Control (QC)
• Quality Management Systems (QMS)
• Inspection Planning & TMV Assessments
• KPI Monitoring and Reporting
• Technical Documentation & Recordkeeping
• Regulatory Compliance & Documentation Control
• Root Cause Analysis (RCA)

Entry level

Other

Quality Assurance

Staffing and Recruiting