Quality Engineering Technician – Cleanroom & Calibration Management

Cretex • Brooklyn Park, MN

12d • $23 - $33

About The Position

Cretex Medical is seeking a Quality Engineering Technician to oversee the operations of our production and cleanroom environments. This role is pivotal in ensuring compliance with cleanroom standards and maintaining the calibration of equipment to uphold product quality and regulatory requirements. The successful candidate will conduct environmental monitoring, manage equipment calibration, perform inspections, and support continuous improvement initiatives.

Requirements

• 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).

Responsibilities

• Conduct 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.
• Complete all activities for the environmental monitoring program to ensure regulatory compliance.
• 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, managing calibration schedules and 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.
• 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.
• Ensure documentation and activities comply with ISO standards and regulatory requirements, maintaining an audit-ready state.

Benefits

• All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), 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 are available to all Cretex employees.
• 20+hours: Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent 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 our discretionary profit sharing program are available to employees working 20+ hours/week.
• 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 are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 251-500 employees