Quality Systems Coordinator II jobs in United States
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Hydrogen Group · 3 days ago

Quality Systems Coordinator II

positionMinnetonka, MN
timeContract
remoteOnsite
seniorityMid Level
money$24/hr - $28/hr
date4+ years exp

Hydrogen Group is seeking a Quality Systems Coordinator II to maintain regulatory compliance and support the integrity of Quality Systems within a regulated environment. The role focuses on managing GxP records, quality event management, and complaint handling activities while collaborating cross-functionally to uphold standards.

EmploymentHuman ResourcesRecruiting
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Administer and monitor quality event processes, ensuring conformance to established standards and tracking operational performance
Sort, categorize, and manage records in alignment with retention schedules, regulatory requirements, and internal procedures
Organize and maintain physical and electronic records to ensure accessibility, accuracy, and traceability
Support complaint handling processes by accurately entering product complaint data into the quality system
Assist with the maintenance, control, and issuance of controlled logbooks
Provide support across Quality System areas, including audits, CAPAs, document control, and training activities
Perform additional duties as assigned to support departmental and organizational objectives

Qualification

Records managementRegulatory complianceGxP knowledgeQuality Management SystemsISO standardsInterpersonal skillsAttention to detailOrganizational skills

Required

High School Diploma or equivalent required
Minimum of 4 years of experience in the life sciences or medical device industry
Strong foundation in records management and regulatory compliance
Familiarity with MasterControl or similar Quality Management Systems
Broad experience across Quality functions, including customer complaint processes
Working knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards
Demonstrates integrity, self-confidence, and a strong commitment to customer and patient safety
Excellent interpersonal and communication skills; able to collaborate effectively across all organizational levels
Strong organizational skills with exceptional attention to detail
Proactive and dependable work ethic with a willingness to learn, take on new responsibilities, and support additional tasks as needed

Company

Hydrogen Group

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Hydrogen Group provides recruitment services for mid to senior level professional staff.
dateFounded in 1997
location
London, England, GBR
people-size201-500 employees
web-link
http://www.hydrogengroup.com

H1B Sponsorship

Hydrogen Group 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
2023 (1)

Funding

Current Stage
Public Company
Total Funding
unknown
2006-10-06IPO

Recent News

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2026-01-13
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Hydrogen group plans formal push for federal funding
2023-01-20
Company data provided by crunchbase