Quality Assurance Inspector

Title:

QA Acceptance Inspector Duration: 12 Months+

Hours:

Monday-Thursday 5AM-2:30PM;
Friday 5AM-9AM (OT as required)

The Quality Assurance Coordinator (Inspector) 40 is responsible for maintaining daily management boards, conducting quality notification processes, and ensuring efficient communication and resolution of quality concerns, working under limited supervision. The role handles delivery hold activities, coordinates daily tasks, and tracks departmental metrics to ensure adherence to quality standards and regulatory requirements. The role contributes to the preparation of nonconforming material documentation for failed inspections or final release activities.

The role interacts closely with stakeholders to resolve discrepancies and deviations, ensuring prompt and accurate documentation of quality issues.

• Inspection Planning Creation Test Method Validation (TMV) assessment.
• Perform incoming inspection and/or final release acceptance activities within warehouse.
• Creation of NCM records for failed acceptance activities.
• Understand device history records and Bill of Materials (BOM).
• Partner with warehouse operations and SQ on resolving quality issues.
• Ensure quality system records (DHR, inspection, and other applicable records) are complete, accurate and comply with procedures.
• Completes Inspection planning tasks for incoming inspection documents.
• Meet departmental metrics:
  Incoming inspection to performance targets, NCM/QN to performance targets, Training completion to target.

• Team oriented mindset;
  Ability to recognize problems, take action, provide feedback.
• Detail oriented;
  Ability to deal with multiple tasks.
• Deliver results – hold self‑accountable, acts with urgency and resilience to deliver on commitments.
• Drive Operational Excellence – Collaborate End2
  
  End and share knowledge and ideas.
• Commitment to Quality – Demonstrates understanding of the Quality System requirements.
• Project/manage incoming inspections, inspection plan creation of purchased finished goods received at the warehouse per established methods.
• Create timely nonconforming records for failed inspections or final release activities.
• Creates inspection plans for incoming inspections and updates work instructions.
• TMV assessments; creates engineering changes and ensures inspection planning requirements are met.
• Responsible to meet departmental metrics.
• Manages daily management board data and may lead meetings.
• Champions lean initiatives and continuous improvement.
• Escalates issues to direct manager.
• Generates departmental metrics and reports to management.
• Completes work with a limited degree to no direct supervision.
• Develop professional expertise; applies company policies and procedures to resolve a variety of issues.
• Serves as an informal resource for colleagues with less experience.
• Organizational, interpersonal skills.
• Technical writing and communication.

Minimum required:
High School Diploma, Vocational Education.

Minimum 2 years of experience in Medical Device, Quality Assurance, Quality Control, Quality Audit, Compliance Coordination or Warehouse Operations or equivalent.

• Quality Assurance (QA)
• Quality Management Systems (QMS)
• Quality Control Inspection KPI Monitoring and Reporting
• Inspection Planning/TMV assessments
• Regulatory Requirements
• Technical Documentation Recordkeeping
• Root Cause Analysis (RCA)

• First Article experience.
• Coordinate measuring machine and other inspection tools.
• TMV knowledge.
• Past measuring equipment experience.
• SAP (MRP/ERP) experience desired.
• Read and understand drawing requirements and tolerances.
• At least 3 years in medical device industry required.
• Prior experience in manufacturing or warehouse environment.
• Basic understanding of CAPA, 21 CFR Parts 803, 806, 820, ISO
  13485, EU MDR.

$30.00/hr – $34.00/hr

Mid‑Senior level

Contract

Other

Medical Equipment Manufacturing

Woodinville, WA