Associate Quality Specialist

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 Associate Quality Specialist position 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. This role processes document control transactions, coordinates site record retention, assists in calibration activities, supports inspection and auditing tasks and assist in other Quality Management System support activities. This role is required to be on-site Monday-Friday 7am-4pm.

Duties

• Process document control transactions.
• Review DHR’s and support batch record release.
• Support the record retention practices within the site.
• Coordinate site calibration activities and recordkeeping.
• Coordinate site inspection activities and recordkeeping.
• Support internal and external auditing processes.
• Support targeted Lean activities.
• Complete other duties as assigned.

Education Degree

High School Diploma or GED

Required Experience

• One (1) year experience preferred in a regulated industry (i.e. FDA/ISO 13485)
• Associate’s degree in related technical field (i.e. Engineering, Chemistry, Biology) preferred.

Pay range for this opportunity is $21.00/hour - $24.00/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.

STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.