Quality Systems Specialist

Location

Mentor, OH | United States

Job description

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 Specialist is responsible for assisting in the 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 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.

This position will overlap 1st and 3rd shifts (e.g. 11 am - 8 pm, etc.).  Open to four (4) 10-hour days per week four or (4) 9-hour days and a 4-hour day per week.

Duties

• Complete document control transactions.
• Manage Customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHR’s and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration activities and recordkeeping.
• Support site inspection activities and recordkeeping.
• Coordinate 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.

Education Degree

• Associate's Degree in Engineering General or Science

Required Experience

• Two (2) years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485).

#LI-BN1

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, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047 . This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs 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.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Job tags

Salary