Operations Quality Technician

Overview

• Contribute to quality assurance in manufacturing, ensuring compliance with corporate policies and federal regulations.
• Perform inspections on incoming materials, in-process products, and final goods to ensure quality standards are met.
• Support production operations, metrology, microbiology, and other manufacturing functions as needed.
• Maintain accurate records and documentation in compliance with Good Manufacturing Practices (GMPs).
• Assist in audits and inspections conducted by regulatory authorities and notified bodies.
• Work in a cleanroom environment, adhering to strict cleanliness and safety standards.
• Utilize various electronic systems for data entry and record maintenance.
• Engage in a fast-paced manufacturing setting requiring strong attention to detail and problem-solving skills.

Key Responsibilities & Duties

• Inspect incoming materials, in-process products, and final goods for quality assurance.
• Record inspection results and maintain accurate documentation in electronic systems.
• Ensure equipment calibration status is up-to-date and compliant.
• Support audits and inspections by regulatory bodies and quality managers.
• Adhere to GMPs, GDPs, and GLPs in all operations and documentation.
• Maintain a clean and safe work environment suitable for medical device manufacturing.
• Collaborate with quality engineers, supervisors, and managers to ensure compliance.
• Perform additional duties as required to support manufacturing operations.

Job Requirements

• High School diploma or GED required; familiarity with measurement instrumentation preferred.
• Experience in a lab setting, particularly in the medical device industry, is advantageous.
• Proficiency in English for documentation, communication, and report writing.
• Basic mathematics skills, including addition, subtraction, multiplication, and division.
• Ability to work autonomously in a fast-paced, multi-tasking environment.
• Physical capability to stand, walk, and lift weights as required by the role.
• Strong attention to detail and problem-solving skills for quality assurance tasks.
• Commitment to maintaining a cleanroom environment and adhering to safety standards.