Quality Specialist
Company: Steris
Location: Mentor
Posted on: June 25, 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.
Duties - cont'd
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.
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
hours.
Keywords: Steris, Mentor , Quality Specialist, Other , Mentor, Ohio
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