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

What You'll Do as a Quality Technician

• Affords assistance 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 in 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.
• Completes other duties as assigned.

Required

• The Experience, Skills and Abilities Needed
• 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.
• PREFERRED: Experience working in a regulated industry (i.e. FDA/13485, ISO 9001)

What STERIS Offers

• 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
• Tuition Reimbursement and continued education programs
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Opportunities for advancement in a stable long-term career

Pay range for this opportunity is $21.00 - $23.00 per hour. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

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