STERIS Canada Corporation
Senior Document & Data Specialist
STERIS Canada Corporation, Chicago, Illinois, United States, 60290
Job Title: Senior Document & Data SpecialistJob Category: Quality
Location: Chicago, IL, US, 60618
Description:
The Senior Document & Data 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.
What We Offer YouThe opportunity to join a company that will invest in you for the long-term. We do this by providing:
Competitive salaries
Healthcare benefits
Tuition assistance
Paid-time off
Paid holidays
Matching 401(k)
Annual merit increases
Annual bonus
What You Will Do
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
What Will Help You Be Successful
Associate's degree required.
Two (2) years experience in Quality in a regulated industry (i.e. FDA/ISO 13485).
PC familiarity with MS Office applications including Word, Excel, and MS Teams.
Pay range:
$63,000.00 - $88,200.00. This position is eligible for bonus participation.
HuFriedyGroup 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.
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Location: Chicago, IL, US, 60618
Description:
The Senior Document & Data 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.
What We Offer YouThe opportunity to join a company that will invest in you for the long-term. We do this by providing:
Competitive salaries
Healthcare benefits
Tuition assistance
Paid-time off
Paid holidays
Matching 401(k)
Annual merit increases
Annual bonus
What You Will Do
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
What Will Help You Be Successful
Associate's degree required.
Two (2) years experience in Quality in a regulated industry (i.e. FDA/ISO 13485).
PC familiarity with MS Office applications including Word, Excel, and MS Teams.
Pay range:
$63,000.00 - $88,200.00. This position is eligible for bonus participation.
HuFriedyGroup 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.
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