Quality Technician

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 (DHR), authorize release of finished product/processes and execute calibration and environmental monitoring processes.

- 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. - Investigate production line stoppages to identify corrective actions. - Identifie and document product and process non-conformances. - Participate in a Material Review Board to review and process non-conformance reports. - Reviews DHR's and supports batch record release. - Enter and retrieve Quality data from local and global systems. - Perform site calibration activities and recordkeeping. - Execute environmental monitoring processes and recordkeeping. - Verifiy calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release. - Complete other duties as assigned.

- 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 working in a regulated industry (i.e. FDA/13485, ISO 9001)

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

- Market Competitive Pay - Extensive Paid Time Off and (9) added Holidays - Excellent Healthcare, Dental and Vision

Benefits - Long/Short Term Disability Coverage - 401(k) with a company match - Maternity and Paternity Leave - Additional add-on benefits/discounts for programs such as Pet Insurance - Tuition Reimbursement and continued education programs - Excellent opportunities for advancement in a stable long-term career

Pay range for this opportuniity is $21.00 - $23.00 per hour. This position is eligible for bonus participation.