Inspector, Quality Control

About the role

Inspector, Quality Control position based in Portland, OR. This is a 100% onsite role with shifts from 7:00 AM to 3:30 PM, for a duration of 12 months.

Responsibilities

• Inspection & Testing: Performs visual and physical inspections of raw materials, in-process components, and finished products to ensure they meet quality specifications. Uses precision measuring tools and lab equipment to verify product dimensions and performance. Previous use of SmartScope Zone 3 and CMM highly preferred.
• Documentation & Compliance: Accurately maintains Lot History Records (LHR), batch records, and inspection logs in compliance with Good Documentation Practices (GDP) and FDA regulations.
• Defect Management: Identifies, classifies, and reports defects. Manages non-conforming material by initiating Non-Conformance Reports (NCR) and assisting with investigations.
• Process Control: Monitors production processes to ensure adherence to standard operating procedures (SOPs) and Good Manufacturing Practices (GMPs).
• Equipment Maintenance: Calibrates, cleans, and performs routine maintenance on inspection and testing equipment to ensure accuracy.
• Collaboration: Works with production and engineering teams to support quality improvements, provide feedback on product quality, and ensure regulatory compliance.

Key Competencies

• Attention to Detail: High level of accuracy in documentation and inspection.
• Computer Literacy: Proficient in using software like SAP, MS Excel, Outlook, Teams.
• Technical Knowledge: Understanding of ISO 13485 and FDA 21 CFR Part 820 regulations.
• Communication: Ability to clearly report deviations and collaborate in a team environment.

Qualifications

• High school diploma or equivalent is required. Associate's or Bachelor's degree in a technical field preferred.
• Previous experience in manufacturing, particularly in medical device, pharmaceutical, or similar regulated industries is highly desired.
• 1+ years of experience desired.

Benefits

Eligible benefits upon waiting period include:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)