QA Acceptance Inspector with Medical Device industry

Jobs via Dice; Woodinville (WA); On-site; USD 60,000 - 75,000; Full time

Job summary

A leading company in the medical device industry seeks a QA Acceptance Inspector in Woodinville, WA. The role involves managing quality inspections, coordinating tasks, and ensuring adherence to quality standards. Candidates should have significant experience and a detail-oriented approach to quality assurance in medical devices.

Qualifications

• 3+ years of experience in a medical device industry.
• Minimum 2 years of experience in Quality Assurance roles.
• Ability to read and understand drawing requirements and tolerances.

Responsibilities

• Conduct quality notification processes and maintain management boards.
• Perform incoming inspection and manage departmental metrics.
• Interact with stakeholders to resolve discrepancies promptly.

Skills

Detail oriented

Team oriented mindset

Problem recognition and action

Organizational skills

Technical writing

Education

High School Diploma

Vocational Education

Tools

Coordinate measuring machine

SAP (MRP/ERP)

Job description

QA Acceptance Inspector with Medical Device industry

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Job Title: QA Acceptance Inspector

ID: PHIAJP00002396

Location: Woodinville WA

12 months

Description:

QA Acceptance Inspector 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. QA Acceptance Coordinator (Inspector) 40

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)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Software Development

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