Urgent Opening // Quality Control Inspector // Bothell, WA, 98021 // Contract-12 Months

Role: Quality Control Inspector III

Location: Bothell, WA, 98021

Job Type: Contract -12 Months

Job Description:

Must Have: Measurment experience.

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

• 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