Quality Assurance Technician

Quality Assurance Technician help support quality assurance activities within a medical device sterilization environment. This role is responsible for ensuring sterilization processes are performed according to validated parameters, regulatory requirements, customer specifications, and internal quality standards. The Quality Assurance Technician will review sterilization documentation, monitor process controls, support product release activities, and maintain compliance with FDA regulations, cGMP requirements, and applicable ISO standards.

The ideal candidate will have strong attention to detail, excellent documentation skills, and the ability to work effectively in a regulated manufacturing environment.

Responsibilities

• Review sterilization cycle records to verify compliance with validated process parameters and established procedures.
• Perform detailed reviews of load documentation and supporting quality records.
• Ensure documentation accuracy and completeness prior to product release.
• Support quality review and approval of sterilized products based on internal procedures and customer requirements.
• Verify critical sterilization process parameters, including temperature, humidity, gas concentration, and dose levels.
• Complete pre-cycle and post-cycle software verification activities.
• Serve as an independent process verifier and witness during sterilization activities when required.
• Support environmental monitoring programs and quality initiatives.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and ALCOA data integrity standards.
• Investigate, document, and escalate abnormal equipment performance, system alarms, or quality concerns.
• Identify and communicate issues that may impact product sterility assurance or regulatory compliance.
• Assist with internal, customer, and regulatory audits and inspections.
• Maintain productivity and quality performance standards while supporting continuous improvement initiatives.
• Follow all safety guidelines, quality procedures, and company policies.
• Complete additional responsibilities and projects as assigned.

Qualifications

• Associate's degree or higher in Science, Quality, or a related technical discipline, or equivalent experience.
• 2–5 years of quality assurance experience in a GMP-regulated industry, preferably within medical device manufacturing or sterilization services.
• Knowledge of sterilization processes and related industry standards.
• Understanding of sterility assurance concepts and quality systems.
• Familiarity with FDA regulations, cGMP requirements, and ISO standards such as ISO 11135, ISO 11137, and ISO 13485.
• Strong attention to detail with the ability to review and interpret technical documentation.
• Excellent organizational skills with the ability to manage multiple priorities.
• Strong analytical, problem-solving, and decision-making abilities.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Strong commitment to quality, compliance, and operational excellence.
• Dependable, punctual, and able to maintain a positive attitude and strong work ethic.
• Must be authorized to work in the United States