Senior Quality Systems Specialist jobs in United States
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STERIS · 1 month ago

Senior Quality Systems Specialist

positionMentor, OH
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$78K/yr - $101K/yr
date5+ years exp

STERIS is a company dedicated to creating a healthier and safer world through innovative healthcare and life science solutions. The Senior Quality Systems Specialist is responsible for overseeing quality functions, ensuring regulatory compliance, managing document control, and leading investigations related to customer complaints and quality audits.

BiotechnologyHealth CareMedical Device
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H1B Sponsor Likelynote

Responsibilities

Manage the document control processes for the site
Lead Customer complaint investigations and ensure complete complaint documentation
Lead CAPA and NCR investigations and ensure proper documentation
Manage the DHR and batch record release process
Manage record retention practices within the site
Coordinate site calibration activities and recordkeeping
Manage site audit activities and recordkeeping
Support supplier quality and Customer assessment activities
Track, trend and analyze Quality data
Support targeted Lean activities
Complete other duties as assigned

Qualification

ISO 13485FDA 21 CFR Part 820Quality analysis toolsDocument controlCAPA investigationsSupplier quality assessmentBachelor's degreeLean activitiesTeam collaboration

Required

Bachelor's degree required in technical fields (i.e. Engineering, Chemistry, Biology)
Minimum five (5) years of experience in a regulated industry (i.e. FDA/ISO 13485)
Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis)

Preferred

Certification: ASQ, QSR, or AAMI certification preferred

Benefits

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term career

Company

STERIS

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STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
dateFounded in 1985
location
Mentor, Ohio, USA
people-size10001+ employees
web-link
http://steris.com

H1B Sponsorship

STERIS has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)

Funding

Current Stage
Public Company
Total Funding
$0.28M
2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO

Leadership Team

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Daniel Carestio
President and CEO, STERIS
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Walter Rosebrough
CEO Emeritus & Senior Advisor
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Recent News

MarketScreener
STERIS Announces Financial Results for Fiscal 2026 Second Quarter
2025-11-05
STERIS plc
STERIS to Host a Conference Call for Fiscal 2026 Second Quarter Results on November 6, 2025
2025-10-22
Newswire
World Patient Safety Day 2025: Ten Technology Leaders Driving Safer Hospitals
2025-09-12
Company data provided by crunchbase