QC Inspector

Quality Control Inspector Summary Responsible for incoming, in-process and final inspections of components, subassemblies and finished good products.

• Inspect medical device components, subassemblies, and finished goods including plastic components and electronics
• Ability to use measurement equipment such as micrometer, calipers, and rulers
• Performs final release activities
• Ensures all Lot History Records (LHRs) and related quality records are complete and accurate
• Initiates nonconformance reports for product that does not meet requirements
• Performs simple mathematical calculations required to assist with inspections including product testing
• Works alongside Manufacturing Operators on a daily basis in support of the production schedule
• Supports the customer return process including product return intake, cleaning or decontamination and inspection
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and
• FDA regulations including compliance to EN ISO 13485 and Medical Device Quality Standards.
• Assists in root cause analysis to resolve issues.
• Provides feedback to Quality leadership regarding product nonconformances
• Works in accordance with quality system procedures.
• Other duties as assigned by Supervisor.

Required Experience

• High school diploma, or equivalent
• 1-4 years of Quality Control Inspection experience in the medical device industry
• Understanding of sampling plan methods
• Ability to read and understand engineering drawings and specifications
• Proficiency required with word processing, spreadsheet and document management software

Preferred Qualifications

• Experience in FDA/GMP/ISO environment preferred.
• Experience working in an ISO Class 8 Controlled Environment
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.

Salary Range: $45-70K