Quality Control Technician

Job Title:

Quality Control Technician Job Description

The Quality Control Technician supports process and product quality by preparing equipment, samples, and materials for testing, conducting environmental monitoring in clean rooms, and reviewing batch records from production. This role also partners with third-party testing laboratories to prepare devices for sterilization, interpret sterility data, and contribute to investigations of non-conformances. You play a key role in ensuring products meet strict quality and regulatory standards in a dynamic, small-company environment.

• Perform environmental monitoring of clean rooms, including humidity and temperature checks and verification of pest control measures.
• Collect, prepare, and submit samples to various internal and external laboratories for further analysis.
• Verify and analyze test results to ensure they meet established specifications and quality system requirements.
• Prepare and mix chemical formulations for production and manufacturing use in accordance with SOPs.
• Execute in-process quality control tasks to monitor product and process performance during manufacturing.
• Maintain accurate maintenance records for all equipment used in quality control and production support.
• Perform daily pre-operational quality control checks of passivation chemistry to ensure proper performance.
• Conduct package visual inspections, seal strength testing, and integrity testing for sterile seals and pouching.
• Review sterilization certificates to determine readiness for full product release.
• Maintain accurate, complete, and organized records of all quality control activities and findings.
• Participate in quality control investigations and corrective and preventive actions (CAPAs) related to non-conformances.
• Verify that quality control measurements are accurate and document results with strong attention to detail.
• Ensure inspections are completed on time and aligned with production priorities and schedules.
• Review manufacturing records, including sterile processing data, test results, certifications, labeling, and paperwork to confirm compliance with specifications and quality system requirements.
• Perform batch record review for production lots to ensure completeness, accuracy, and adherence to procedures.
• Collaborate with third-party sterilization and contract testing laboratories by preparing devices for sterilization and entering sterility data into documentation systems.
• Support investigations by analyzing data from non-conformances and assisting in the development of investigation plans.
• Follow standard operating procedures consistently and escape quality concerns if something appears out of scope.

• Associates or Bachelor’s degree in a science-related discipline.
• At least 2 years of experience in a regulated industry such as medical device, pharmaceutical, or food.
• Demonstrated quality mindset and willingness to speak up when issues or out-of-scope activities are identified.
• Proven ability to follow standard operating procedures (SOPs), verified through references.
• Experience in quality control or quality assurance within a regulated environment.
• Hands-on experience with environmental monitoring in clean rooms.
• Knowledge of microbiology principles and laboratory practices relevant to product and process testing.
• Understanding of Good Manufacturing Practices (GMP) and their application in daily work.
• Experience with sterilization processes and working with sterile products or environments.
• Ability to apply aseptic techniques when handling materials and samples.
• Experience supporting or executing corrective action plans and CAPAs.
• Strong investigation and analysis skills for evaluating non-conformances and quality issues.
• High attention to detail in documentation, record-keeping, and data entry.
• Ability to maintain accurate equipment maintenance and quality records.
• Capability to prepare and mix chemical formulations safely and accurately.
• Comfort working in both cleanroom and production environments and transitioning between hands-on and documentation tasks.

• Experience in the medical device industry.
• Experience working with third-party sterilization laboratories or contract testing labs.
• At least 6 months of sterilization or environmental monitoring experience in a regulated environment such as medical device, pharmaceutical, food, brewery, or aerospace.
• References who can speak to your commitment to quality and adherence to SOPs.
• Interest in career…