Quality Technician II

Quality Technician II

The Quality Technician is responsible for assuring that company products have been manufactured, inspected, and tested using company approved procedures. Work with manufacturing and QA to implement solutions to quality related problems.

Description of Work

Perform a wide variety of audits, inspections, checks, tests, and sampling procedures to ensure quality of manufactured goods and adherence to quality procedures. Maintain “qualified” status on all quality audits, inspections, testing, and equipment procedures. Coordinate training/cross-training of new and/or existing employees. With direction from supervisor, coordinate quality activities (i.e., inspections, testing, audits) based on manufacturing and/or Research & Development activities. Alert supervisor and/or department engineer of any situation that prevents the Quality Technicians from achieving optimum efficiency. Work with department engineers on development/modification of test methods for new and/or existing products. Write and update inspection procedures and checklists as required. Propose document changes, as necessary, to supervisor or engineers to ensure GMP compliance. Check lot history records for completeness, accuracy, and conformance to SOP. Monitor calibration and maintenance of all test equipment and fixtures and operation of equipment.

Required Skills & Experience

• High school diploma
• 5+ years relevant experience in medical devices
• Problem-solving skills
• Clear communication, both written and verbal
• Work well with others
• Flexible and adaptable – comfortable working in a dynamic environment

Preferred Skills & Experience

• Ability to adapt quickly and deal calmly within an environment in which changes can occur frequently.
• Ability to be self-motivated and self-directed while maintaining good communication with the rest of the team.