Quality Specialist
Company: Steris
Location: Mentor
Posted on: June 25, 2022
|
|
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
Click
here to apply!
|