Job Title:  Quality Technician

Position Summary

The Quality Technician is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem-solving investigations and conducting in-process sub-assembly and final QC product acceptance testing.  Quality Technicians assist in identifying and documenting process and product non-conformances.  They work with operations team members to perform and document problem-solving investigations.  In addition, Quality Technicians may review device history records, authorize release of finished product/processes and execute calibration and environmental monitoring processes.

Duties

• Assists in production line Quality investigations and associated problem-solving activities.
• May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
• Investigates production line stoppages to identify corrective actions.
• Identifies and documents product and process non-conformances.
• Participates on a Material Review Board to review and process non conformance reports.
• Reviews DHR’s and supports batch record release.
• Enters and retrieves Quality data from local and global systems.
• Performs site calibration activities and recordkeeping.
• Executes environmental monitoring processes and recordkeeping.
• Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
• Complete other duties as assigned.

Education Degree

Required Experience

• Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.  Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an Associate Degree.
• Experience with mathematical skills including ratios, proportions and basic algebra.

Skills

• Ability to work in a fast-paced environment with strict deadlines
• Ability to generate detailed, high-quality documentation.
• Ability to work with others in analyzing and solving technical problems.
• Teamwork: Collaborates with others. Works in a professional manner to support team actions. 
• Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.
• PC experience and working familiarity of common desktop applications including Excel and Word.

Working Conditions

Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.