Quality Management System Specialist

MOLEKULE GROUP, INC•Lakeland, FL

1d•Onsite

About The Position

Molekule is a science and clean technology start-up that has completely reinvented the air purifier using a revolutionary new technology. Powered by 20 years of R&D, Molekule’s technology destroys airborne pollutants (pathogens, VOCs, SOx, NOx, etc.) instead of trying to trap them on filter surfaces. We believe that healthy lifestyles start by improving something you do every second of every day, breathe. We’re looking for people who are passionate about health, science, and technology and are excited to build products that fundamentally improve our everyday lives. Come help us build the next generation of air purification technology! We’re looking for a QMS Specialist to join our growing team. This individual will be responsible for Implementing and auditing the necessary quality system programs to ensure Molekule products and facilities are compliant with regulatory requirements including ISO 13485 and FDA QSR requirements.

Requirements

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

Nice To Haves

Experience with Greenlight Guru is a plus.

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.