Quality Specialist
Company: Steris
Location: Mentor
Posted on: August 3, 2022
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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 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. Duties 1. Complete document control transactions.
2. Manage Customer complaint investigations and complete complaint
documentation. 3. Facilitate CAPA and NCR investigations and may
coordinate investigation documentation. 4. Review DHR---s and
support batch record release. 5. Manage record retention practices
within the site. 6. Manage site calibration activities and
recordkeeping. 7. Support site inspection activities and
recordkeeping. 8. Coordinate internal and external audits. 9.
Support supplier quality and Customer assessment activities. 10.
Track and trend site Quality data. 11. Support targeted Lean
activities. 12. Complete other duties as assigned. Education Degree
Associate's Degree Required Experience Describe specific work
requirements, including years of experience for each requirement:
1. Two (2) years experience in a regulated industry (i.e. FDA/ISO
13485) Describe specific skills and/or business competencies: 1.
Customer Focused: Demonstrates a ---Customer first--- mindset.
Responds with a sense of urgency. 2. Teamwork: Collaborates with
others. Works in a professional manner to support team actions. 3.
Results: Effectively manages work tasks. Is detail oriented and
strives for continuous improvement. Ability to analyze technical
issues. Ability to cope with change and shifting priorities. 4.
Communication: Constructs clear written communication. Keeps
manager and co-workers informed. 5. Job Knowledge: PC experience
and working familiarity of common desktop applications including
Excel and Word. STERIS is a leading provider of products and
services that meet the needs of growth areas within Healthcare:
procedures, devices, vaccines and biologics. We exist to fulfill
our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER
WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with
approximately 16,000 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.
Keywords: Steris, Mentor , Quality Specialist, Other , Mentor, Ohio
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