Quality Control Inspector III
Location
Bothell, WA | United States
Job description
Summary:
QA Acceptance Inspector:
- 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 activitiesUnderstand 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
Roles & Responsibilities:
- 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.
- 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.
Minimum Qualifications:
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
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.
- 2 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.
Required Skills:
Quality Control Inspector
Work Authorization
Benefits:
Job tags
Salary
$31 per hour
