Posted on: June 25, 2022
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
6.-- --- - -- -Manage site calibration activities and
7.-- --- - -- -Support site inspection activities and
8.-- --- - -- -Coordinate internal and external audits.
9.-- --- - -- -Support supplier quality and Customer assessment
10.-- --- - -- -Track and trend site Quality data.
11.-- --- - -- -Support targeted Lean activities.
12.-- --- - -- -Complete other duties as assigned. Duties - cont'd
Education Degree Associate's Degree Required Experience Describe
specific work requirements, including years of experience for each
1. Two (2) years experience in a regulated industry (i.e. FDA/ISO
13485) -- - Describe specific skills and/or business
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
5.-- --- - -- -Job Knowledge: PC experience and working familiarity
of common desktop applications including Excel and Word.
-- - Preferred Experience Skills -- - 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
Keywords: Steris, Mentor , Quality Specialist, Other , Mentor, Ohio
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