Quality Systems Technician I jobs in United States
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Fresenius Medical Care · 5 hours ago

Quality Systems Technician I

Fresenius Medical Care is a healthcare company focused on providing quality medical devices. They are seeking a Quality Systems Technician I to conduct quality audits, prepare documentation, and assist in maintaining product integrity and compliance with industry standards.

BiotechnologyHealth CareMedical Device
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H1B Sponsor Likelynote

Responsibilities

Under close supervision, acquires job skills and learns company policies and procedures to complete routine tasks. Fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations
Develop plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories
Works on assignments that are routine in nature; determines whether or not communications regarding company equipment are complaints and whether or not complaints might be reportable to the FDA
Analyzes equipment complaints to determine the probability that the reported problem is resolved and, if not, whether additional action to resolve the problem needs to be taken
Assures laboratory equipment and instrumentation is calibrated and properly maintained
Performs operation, including routine maintenance/cleaning for analytical instruments to ensure proper operation
Documents investigation steps and results
Communicates with company personnel to investigate complaints
Follows all policies, guidelines, and Standard Operating Procedures (SOPs) as required
May refer to senior staff for assistance with day-to-day problems that may arise
Escalates issues to supervisor for resolution, as deemed necessary
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations
Assists with various projects as assigned by direct supervisor
Other duties as assigned

Qualification

Quality auditsISO-9001 standardQSR regulationsAnalytical instrumentsMathematical aptitudeBasic computer skillsCommunication skillsAttention to detail

Required

High School Diploma required
Minimum 0 – 1 years of related experience
Understands basic concepts and principles of dialysis
Mathematical aptitude required with a good background in algebraic skills and measurement skills
Basic computer skills with database, spreadsheet, and word-processing programs
Strong oral and written communication skills
Strong attention to detail

Preferred

Associate's Degree or Bachelor's Degree in Science preferred (Chemistry or Microbiology preferred)

Company

Fresenius Medical Care

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Fresenius Medical Care is a healthcare company that provides dialysis treatment for those with chronic kidney diseases.

H1B Sponsorship

Fresenius Medical Care 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 (2)
2024 (5)
2023 (14)
2022 (18)
2021 (10)
2020 (20)

Funding

Current Stage
Public Company
Total Funding
$758.43M
2025-11-17Post Ipo Debt· $579.5M
2025-07-21Post Ipo Equity· $4.86M
2020-02-25Post Ipo Equity· $6.07M

Leadership Team

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Helen Giza
Chief Executive Officer
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Joseph Turk
CEO of Care Enablement and Member of the Management Board of Fresenius Medical Care
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Company data provided by crunchbase