Quality Assurance Inspector

Title : QA Acceptance Inspector

Location : Woodinville, WA

Duration : 12 Months+

Hours- with OT as required Monday- Thursday 5AM 2 : 30PM Friday 5AM to 9AM

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.

KEY AREAS OF RESPONSIBILITIES

QA Acceptance Coordinator : Inspection Planning Creation Test Method Validation (TMV) assessment Follow assigned procedures and complete all training records. 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, 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

REQUIRED COMPETENCES

• 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 End2End and share knowledge and ideas.
• Commitment to Quality - Demonstrates understanding of the Quality System requirements Job Overview Performs timely incoming inspection and inspection plan creation of purchased finished goods received at the warehouse per established methods.
• Creates timely nonconforming records for failed inspections or final release activities. Created 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. Responsible to champion 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. Developing professional expertise, applies company policies and procedures to resolve a variety of issues for direct area of responsibility.
• Likely to act as an informal resource for colleagues with less experience. Developed professional expertise, applies company policies and procedures to resolve a variety of issues for direct area of responsibility. Has developed specialized skills and is multi-skilled through job related training and considerable on the job training / experience. organizational, interpersonal skills required. Technical writing, communication, and organizational, interpersonal skills required. Experience & Background Able to complete set-up and inspections with a coordinate measuring machine and other inspection tools as necessary. Test Method Validations (TMV) knowledge. Past measuring equipment experience.
• First Article experience. SAP (MRP / ERP) experience desired. Able to read and understand drawing requirements and tolerances. 3+ years of experience in a medical device industry required. Prior experience in working in a manufacturing or warehouse related environment, required. Basic understanding of CAPA, as well as global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and EU MDR.

Minimum required Education : High School Diploma, Vocational Education. Minimum required

Experience : Minimum 2 years of experience in Medical Device, Quality Assurance, Quality Control, Quality Audit, Compliance Coordination or Warehouse Operations or equivalent. Preferred Skills : 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),1)