Quality Engineering Technician

Responsibilities

• Carry out monthly environmental monitoring (particulate and microbial testing) in Class 7 and Class 8 cleanrooms.
• Coordinate with external labs for testing and compile environmental reports, analyzing data to identify trends and implementing corrective actions as needed.
• 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.
• Maintain and manage calibration schedules for manufacturing and cleanroom equipment, coordinating with outside calibration services as needed.
• Conduct process audits to verify adherence to 5S standards and quality protocols.
• Participate in root cause analysis and corrective actions to resolve non-conformances and support CAPA and customer complaint processes.
• Support continuous improvement initiatives to enhance cleanroom practices, equipment reliability, and quality-related processes.

Qualifications

• Associate degree in Engineering, Biology/Microbiology, or a 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 the ability to manage multiple tasks effectively.
• Excellent verbal and written communication skills, with 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 Geometric Dimensioning and Tolerancing (GD&T).

Benefits

• All Employees: 401k retirement savings plan with a company match contribution; onsite health clinics; discretionary holiday bonus program; Cretex University; 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost; wellness program with incentives; an employee death benefit; and employee sick and safe leave.
• 20+hours: Comprehensive medical insurance with access to virtual providers; dental insurance covering services 100% for children 12 and younger when seen by a Health Partners in network provider; vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and discretionary profit sharing program.
• 30+ hours: Parental leave; accident and critical illness benefits; optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs.