Quality Technician - Molding & Assembly - 1ST SHIFT at Cretex Medical Component and Device Technologies in Brooklyn Park, Minnesota

Job Description:

Overview




About Cretex Medical



Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.



Position Summary:


The Quality Technician Molding & Assembly ensures the quality and compliance of medical components through advanced dimensional and visual inspections. This role is responsible for operating precision inspection equipment, analyzing data using Statistical Process Control (SPC), and supporting process improvements. The technician will also collaborate with cross-functional teams, improve processes, maintain quality records, and ensure adherence to ISO 13485 and FDA 21 CFR 820 standards.

Responsibilities

• Conduct dimensional and visual inspections for first article, gage R&R, process capability studies, and final product release.
• Operate, program, and maintain inspection equipment such as CMMs, vision systems, and tool scopes, while ensuring equipment is calibrated and functioning properly.
• Analyze inspection data using Statistical Process Control (SPC) to detect trends, monitor process stability, and recommend corrective actions to improve manufacturing processes.
• Provide training to operators and quality personnel on proper inspection techniques, equipment usage, and documentation practices to ensure adherence to quality standards.
• Support root cause analysis and CAPA activities, contributing to problem-solving efforts for non-conformance issues.
• Perform DHR (Device History Record) reviews and ensure final lot release is completed per Good Documentation Practices (GDP) requirements.
• Maintain accurate and timely quality documentation within the ERP system, ensuring traceability and compliance with company and regulatory requirements.
• Collaborate with cross-functional teams, including engineering, production, and quality, to address quality concerns, implement process improvements, and ensure product conformance.
• Ensure compliance with the company's Quality Management System (QMS), including ISO 13485, FDA 21 CFR 820, and other applicable medical device regulations.
• Sustain an organized and cleanroom work environment using 5S principles to reduce waste and contamination risk in cleanroom operations.

Qualifications

• High School diploma or equivalent.
• Minimum of 3 years of experience in quality assurance, preferably in a regulated industry.
• Proficiency in visual inspection, inspection hand tools, and operating inspection equipment (e.g., CMM, vision systems, tool scopes).
• Strong problem-solving skills with the ability to analyze data and resolve nonconformances.
• Ability to manage multiple tasks and meet deadlines in a fast-paced manufacturing environment.

Preferred Qualifications:

• Minimum of 3 years of experience in a regulated manufacturing environment, ideally in the medical device or a similar industry.
• Knowledge of ISO 9001/13485 standards and regulatory compliance.
• Experience working in a cleanroom environment
• Relevant quality certifications, such as ASQ Certified Quality Technician (CQT) or equivalent.

Cretex Companies may use cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels

Pay Range

USD $22.40 - USD $27.45 /Hr.Company Benefits




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.) Apply Now