Quality Engineering Technician

Position Summary

Quality Engineering Technician to oversee operations of production and cleanroom environments. Ensures compliance with cleanroom standards and maintains equipment calibration to uphold product quality and regulatory requirements.

• Conduct monthly environmental monitoring (particulate and microbial testing) in Class 7 and Class 8 clean rooms.
• Coordinate with external labs for testing and compile environmental reports, analyzing data to identify trends and implement corrective actions.
• Assist engineers in validation and verification activities supporting compliance and process integrity.
• Update and maintain cleanroom and calibration documentation, ensuring audit readiness.
• Perform sterilization and cleaning tests supporting study requirements, routine radiation dose audits, and EO re‑qualification.
• Monitor, inspect, set up, calibrate, and maintain manufacturing and cleanroom equipment; manage calibration schedules and coordinate with outside calibration services.
• Conduct process audits to verify adherence to 5S standards and quality protocols.
• Participate in root‑cause analysis and corrective actions to resolve non‑conformances; support CAPA and customer complaint processes.
• Support continuous improvement initiatives to enhance cleanroom practices, equipment reliability, and quality‑related processes.
• Provide training and guidance to staff on cleanroom protocols, equipment usage, and calibration procedures.
• Apply blueprint reading and GD&T knowledge to support inspection and process quality.

• Associate degree in Engineering, Biology, Microbiology, or related technical field.
• 2–5 years in a quality role within a regulated environment, preferably in medical device manufacturing or cleanroom operations.
• Proficiency in cleanroom standards (ISO Class 7 and Class
  8) and environmental monitoring techniques.
• Experience with equipment calibration and maintenance, including managing calibration schedules and records.
• Strong organizational skills with attention to detail and ability to manage multiple tasks.
• Excellent verbal and written communication skills; proficiency in technical writing and documentation.
• Familiarity with applicable AAMI, ASTM, and ISO standards related to medical device sterilization and cleaning.
• Ability to read and interpret engineering drawings and specifications including GD&T.

Use of cutting oils, solvents, and other chemicals; periodic testing to ensure chemical exposure is below OSHA permissible levels.

USD $23.08 – $33.46 /hr.
Benefits include: 401(k) retirement savings plan with company match, onsite health services, discretionary holiday bonus, medical, dental, and vision insurance, pre‑tax health savings account, paid holidays, paid time off, profit‑sharing program, parental leave, accident and critical illness benefits, optional life insurance, disability coverage, tuition assistance.

Applicants will receive consideration for employment regardless of race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, or any other protected status.

Our company uses E‑Verify to confirm employment eligibility of newly hired employees.