Job Overview:
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.
Hours: 8:00am-4:30pm Monday-Friday
Benefits: Healthcare, Vision, Dental, 401K Match, Quarterly Bonuses, PTO, Company Holidays
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.
Duties - cont'd
- 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
Education DegreeHigh School Diploma or GEDRequired 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.
Job Type: Full-time
Pay: $19.00 - $21.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Retirement plan
- Vision insurance
Experience level:
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Work setting:
Work Location: In person