Molekule · 3 days ago
Quality Management System Specialist
Lakeland, FL
Full-time
Onsite
Mid Level
3+ years expMolekule is a science and clean technology start-up that has reinvented the air purifier using revolutionary technology. They are seeking a QMS Specialist responsible for implementing and auditing quality system programs to ensure compliance with regulatory requirements including ISO 13485 and FDA QSR.
ElectronicsGreen Consumer GoodsGreenTech
Responsibilities
Own the electronic QMS tool, Greenlight Guru, to ensure ISO13485 and FDA QSR requirements are met
Provide compliance direction, investigate complaints and verify deficiencies are corrected
Ensure maintenance of all product quality files including design history and technical files
Track, report and complete Corrective and Preventive Actions, Nonconformances and Post Market Surveillance/Vigilance activities
Assist with external regulatory/quality audits by customers and FDA
Assist with quality inspection of Molekule’s products and components
When necessary lead or facilitate Root Cause Analysis investigations
Gather data for activities and status regarding key regulatory, productivity and management review indicators
Assist, conduct, and report routine internal Quality Management System (QMS) audits to ensure compliance
Implement procedural updates due to changes in regulations (FDA QSR, 13485, and other regulatory requirements)
Assist with the evaluation of proposed design changes, specifications, and drawing releases as related to compliance requirements per the Change Control process
Support process control improvement by creating new, or updating existing production processes and test procedures as required
Execute employee communication and training programs that focus on the elements of a companywide Q&R program
Qualification
Required
Bachelor's degree in science or related field
3+ years' Quality Management System experience; experience with Class II medical devices strongly preferred
Expertise in FDA regulations, as well as demonstrated experience with interpreting and monitoring them
Proficient computer skills, especially with Microsoft Excel, PowerPoint and electronic QMS programs
Strong analytical capabilities
Excellent communication skills and clear writing
Preferred
Experience with Greenlight Guru is a plus
Benefits
Health, dental and vision insurance & more
Unlimited discretionary time off (DTO)
Matching 401K
Flexibility (i.e. work day start and end times)
Company
Molekule
Molekule provides FDA-cleared air purification devices to address the growing global air purification industry.
51-200 employees
H1B Sponsorship
Molekule 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 (2)
2022 (6)
2021 (1)
2020 (5)
Funding
Current Stage
Growth StageTotal Funding
$125.15MKey Investors
Kevin LoveRPS VenturesFoundry Group
2025-05-15Series Unknown· $6.6M
2022-06-22Series Unknown· $22.2M
2021-09-17Angel
Leadership Team
Yogi Goswami
Co-Founder and Chief Science & Technology Advisor
Ryan Tyler
Chief Financial Officer
Recent News
2025-02-11
techbuzzireland.com - Leading real hands on tech review site in Ireland with technology, business news and more. Jim O Brien Tech.
2025-02-05
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