Seeking a Quality Control Technician II to support the Quality Control (QC) department within the Toxicology Business Unit. This role is responsible for performing in-process and final QC testing of in-vitro diagnostic devices to ensure product quality and compliance with FDA, ISO, and other regulatory requirements. The position involves documentation of test results, identifying defects, and participating in root cause investigations and validation studies.

Key Responsibilities:

• Conduct incoming, in-process, and final product testing.
• Maintain accurate records and documentation in compliance with GMP standards.
• Train new staff and cross-train in various QC lab functions.
• Use lab equipment such as analytical balances, optical comparators, calipers, gauges, etc.
• Utilize Agile for quality incidents and investigations.
• Ensure timely product release and maintain lab cleanliness.

Qualifications:

• High school diploma required; 2–5 years of relevant lab experience.
• Experience in a GMP environment and working knowledge of lab instruments.
• Proficient in MS Office; experience with semi-automated equipment is a plus.
• Preferred experience in medical device manufacturing and knowledge of regulatory standards (FDA, ISO, OSHA).

Core Competencies:

• Strong attention to detail
• Effective communication skills
• Team-oriented mindset
• Results-driven approach