Quality and Regulatory Specialist
Tampa, FL /
Operations – Operations /
"Best Places to Work 2019" -SF Business Times
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 Quality and Regulatory 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. This person will also help on the Regulatory side with medical device submissions both in the U.S.A. and Internationally.
What you'll work on:
- Provide compliance direction, investigates complaints and verifies deficiencies are corrected.
- Ensure maintenance of all product quality files including design history and technical files.
- Assist with Regulatory Submissions both FDA and International.
- Track, report and complete Corrective and Preventive Actions.
- Assist with external regulatory/quality audits by customers and FDA.
- May 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
- Support process control improvement by creating new, or updating existing production process and test procedures as required.
- Execute employee communication and training programs that focus on the elements of a companywide compliance program.
Who we're looking for:
- Bachelor’s degree in science or related field
- 5+ years' Quality Management System experience; experience with Class II medical devices strongly preferred
- Expertise in FDA regulations, as well as demonstrated experience in interpreting and monitoring them
- Proficient computer skills, (Microsoft Excel, PowerPoint, Google Suite, and electronic QMS)
- Strong analytical capabilities
- Excellent communication skills, both written and verbal
We are Molekule and we’re changing air purification. Molekule uses 25 years of breakthrough science to destroy airborne pollutants, delivering clean air. Our mission isn’t just making air purifiers, but cleaning the air everywhere. It’s a lofty goal, but that's why we need you.
"Check your ego at the door."
Determination & Grit
"We believe in what we're doing. That's why we persevere through problems."
"We roll up our sleeves, do the work, own the outcomes, and are proud of our contributions (no matter the size)."
"We're all in this together."
"We're devoted to changing the world for the better."
"I know that I don't know everything, there's always more to learn. I learn from my mistakes."
"My communications are candid, effective, respectful, and assuming good intentions."
Every great accomplishment is the result of a team working in harmony, not just of individuals. We believe teamwork and a sense of egalitarian responsibility is fundamental to building a great organization.
The objective of all organizational processes is to turn our organization into something scalable, repeatable, and efficient that reflects our culture.
Molekule is an Equal Opportunity/Affirmative Action Employer. We will consider employment for qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance. The Company will also not discharge, or in any manner discriminate or retaliate against, any employee who discloses their own wages, discusses the wages of others, inquires about another employee’s wages, or aids or encourages any other employee to do the same. The Company is not obligated to disclose wages.
Applicants with disabilities may e-mail HR@molekule.com or text or call 415.439.0018, to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time.