Senior Quality Control Chemist Technician

Senior Quality Control Technician for our medical device manufacturing client in St. Paul, MN
. In this role, you will be responsible for performing quality control inspections, laboratory testing, and product acceptance activities for sterile and non-sterile medical devices. The Senior Quality Control Technician will ensure products meet approved specifications, procedures, customer requirements, and applicable regulatory standards while supporting manufacturing, laboratory, and quality operations.

Industry: Medical Device Manufacturing

Location: St. Paul, MN

Compensation: $28/hr

Type: Direct Hire

• Perform incoming, in-process, final, and finished product QC inspections to verify conformance to specifications, customer requirements, and quality system requirements.
• Perform accurate measurements and document inspection and testing results with a high level of attention to detail.
• Ensure inspections and testing activities are completed in accordance with production schedules and established priorities.
• Review manufacturing records, sterile processing documentation, test results, certifications, labeling, and related paperwork for compliance with specifications and quality system requirements.
• Support Warehouse associates to ensure materials are properly handled and stored according to specifications and quality system requirements.
• Collect, prepare, and submit samples to internal and external laboratories.
• Prepare sterilization documentation and analyze sterilization and biological indicator results.
• Perform UV-Vis, FTIR, and basic wet chemistry testing and analyze results against established specifications.
• Prepare and mix chemical formulations for Production and Manufacturing use.
• Perform environmental monitoring activities, including temperature and humidity monitoring and controlled environment testing.
• Identify, document, segregate, and quarantine nonconforming materials to prevent unintended use.
• Assist with investigations involving products or processes suspected of being nonconforming.
• Coordinate Material Review Board activities and support timely disposition of nonconforming materials.
• Communicate with applicable stakeholders regarding materials awaiting MRB review, action, or disposition.
• Maintain controlled access to QA Hold and Quarantine areas.
• Inspect returned goods and ensure nonconforming materials are appropriately segregated.
• Maintain the equipment calibration program to ensure production, test, and measurement equipment is calibrated by required due dates.
• Verify equipment is appropriately identified with calibration status and remove equipment from service when calibration is expired or out of specification.
• Verify preventive maintenance and equipment qualification activities are completed as required.
• Assist with maintaining Quality Assurance work instructions in accordance with current regulations, standards, and quality system requirements.

• Licensure and/or Experience
• Associate degree or higher in a STEM-related discipline required.
• 3+ years of experience in quality control and inspection within a medical device manufacturing environment.
• Experience preparing technical reports, analyses, and documentation using Microsoft Office.
• Ability to interpret blueprints, technical documentation, specifications, and procedures.
• Working knowledge of analytical chemistry.
• Applied knowledge of quality control, inspection methodologies, and test and measurement instrumentation.
• Experience using measurement and inspection instruments including gauges, micrometers, calipers, indicators, comparators, and microscopes.
• Strong attention to detail with the ability to produce precise measurements, documentation, and quality records.
• Excellent written and verbal communication skills with the ability to communicate effectively with auditors, suppliers, management, and cross-functional teams.
• Excellent hand-eye coordination and visual acuity, including color vision, close vision, and the ability to identify fine details under magnification.

• Two-year technical degree.
• Training or certification related to ISO 13485 and FDA quality systems.
• Experience with sterilization, microbiology, and chemistry.
• Knowledge of Good Laboratory Practices.
• Strong manual dexterity.

• Regularly required to stand, walk, sit, and use hands to manipulate, handle, or operate objects, tools, controls, and office equipment.
• Frequently required to communicate verbally and hear.
• Occasionally required to lift and/or move up to 10 pounds.
• Specific vision requirements include close vision, color vision, and the ability to adjust focus.
• Reasonable accommodations may be provided to enable individuals with disabilities to perform the essential functions of the position.

Estimated Min Rate
: $36400.00

Estimated Max Rate
: $55000.00

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