Quality Assurance Coordinator

Axelon Services Corporation; Woodinville (WA); On-site; USD 50,000 - 70,000; Part time

Job summary

A staffing and recruiting firm is seeking a Quality Assurance Coordinator in Woodinville to ensure product quality through inspections and compliance with regulatory standards. This entry-level position requires a minimum of a high school diploma and knowledge of quality assurance processes. The ideal candidate will have strong problem-solving skills and a commitment to operational excellence. Previous experience in the medical device industry is preferred and the role encourages self-motivation and organizational skills.

Qualifications

• 3 years of experience in the medical device industry preferred.
• Prior work in manufacturing or warehouse environments required.
• Ability to read engineering drawings and tolerances.

Responsibilities

• Perform incoming and final release inspections of purchased finished goods.
• Create inspection plans and update work instructions.
• Collaborate with warehouse operations to resolve quality issues.

Skills

Quality Assurance (QA)

Quality Management Systems (QMS)

Inspection Planning

Test Method Validation (TMV)

Regulatory Compliance

Root Cause Analysis (RCA)

Technical Documentation

Education

High School Diploma or Vocational Education

Additional certifications in Quality or Inspection

Tools

SAP (MRP/ERP) systems

Job description

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

Job Overview

• 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.

Key Responsibilities

• 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.

Experience & Background

• 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.

Education

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

Preferred Skills

• 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)

Seniority level

Entry level

Employment type

Other

Job function

Quality Assurance

Industries

Staffing and Recruiting