Job Title:

Quality Technician

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

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

High School Diploma or GED

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.

You should be proficient in:

Quality Control Data Analysis
Quality Inspection Experience
Basic Computer Skills
Experience in a Manufacturing Environment
High School / GED
Hazardous Materials
ISO 9001 Certification Experience

Machines & technologies you'll use:

Quality Control Software