Quality Systems Engineer jobs in United States
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DEKA Research & Development · 21 hours ago

Quality Systems Engineer

DEKA Research & Development is seeking a Quality Systems Engineer to work in their Quality Department within a dynamic Medical Device Research and Development environment. This role involves administering the Quality Management System and ensuring compliance through various quality-related responsibilities.

3D PrintingMedical DeviceSoftwareManufacturingDeveloper Platform
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H1B Sponsor Likelynote

Responsibilities

Administer the (electronic) Quality Management System
Review and Approve Quality System Records including Complaint records
Process changes for QMS Procedures (SOPs)
Make red-line changes
Make new master documents, archive and distribute via electronic system
Track training for QMS documents within the Change Order process
Track open impacts to completion
Act as Lead Training Coordinator and CAPA Coordinator
Administer the site calibration program
Support the site Corrective and Preventive Action program
File records manually and electronically
Support QMS collection and trending of quality data
Use statistical tools to monitor and report on quality metrics
Manage QMS databases for action items and implementation
Support vendor qualification and management
Support external and internal audits
Aid in the development of training programs
Provide training as required to company personnel
Generate quizzes or other methods to ensure competency following training

Qualification

Quality Management SystemRegulated field experienceAuditing experienceStatistical toolsMultitaskingReport developmentTraining developmentCommunication skills

Required

2+ years' experience in QMS or document centric environment with degree in Engineering or Science degree/background or 3+ years' QMS or document centric environment without degree
Experience with documentation in a regulated field (medical device preferable)
Strong written/verbal communication skills
Ability to learn custom software programs
Ability to multitask and carry tasks through to completion
Ability to manage multiple sources of data and develop reports

Preferred

Prior auditing experience is a plus

Company

DEKA Research & Development

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DEKA Research & Development provides technology solutions for power, mobility, and water applications along with fluid management.

H1B Sponsorship

DEKA Research & Development 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 (13)
2024 (13)
2023 (23)
2022 (16)
2021 (9)
2020 (7)

Funding

Current Stage
Late Stage

Leadership Team

C
Chris Langenfeld
Chief Engineer of Advanced R&D
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Thomas Bollenbach
Project Manager
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Company data provided by crunchbase