Associate Quality Specialist
Position Summary
As an Associate Quality Specialist you will be responsible for administering of all site’s quality functions relating to customers and the adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.
What You Will Do
- Complete document control transactions.
- Review customer complaints and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review DHRs and support batch record release.
- Manage record retention practices within the site.
- Manage site calibration activities and recordkeeping.
- Support site inspection activities and recordkeeping.
- Aids in internal and external audits.
- Support supplier quality and Customer assessment activities.
- Track and trend site Quality data.
- Support targeted Lean activities.
- Complete other duties as assigned.
Required
- High school graduate/GED
- Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)
What STERIS Offers
- Market Competitive Pay
- Extensive Paid Time Off and (9) added holidays
- Long/short Term disability coverage
- 401(k) with company match
- Tuition Reimbursement and continues educations programs
Pay Range
The Pay range for this opportunity is $20.84 - $26.97. 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.
Benefits
Click here for a complete list of benefits: STERIS Benefits
Contact Information
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.
About STERIS
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe.