Quality Management System Specialist

MOLEKULE GROUP, INC; Lakeland (FL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health, dental and vision insurance

Unlimited discretionary time off

401K matching

Flexible schedule

Job summary

Molekule is seeking a QMS Specialist to implement and audit quality systems ensuring ISO 13485 and FDA QSR compliance for products and facilities. This role manages the electronic QMS (Greenlight Guru), drives CAPAs, and collaborates with audits, design controls, and process improvements in a manufacturing environment.

Ideal candidates have a science degree, 3+ years of QMS experience, and strong communication skills to support regulatory readiness and product quality initiatives.

Qualifications

• Bachelor's degree in science or related field.
• 3+ years’ QMS experience; Class II medical devices preferred.
• Expertise in FDA regulations and interpretation.
• Proficient with Microsoft Excel, PowerPoint and electronic QMS systems.
• Greenlight Guru experience is a plus.
• Strong analytical capabilities.
• Excellent communication and clear writing.

Responsibilities

• Own the electronic QMS tool (Greenlight Guru) to meet ISO13485 and FDA QSR.
• Provide compliance direction, investigate complaints and verify corrections.
• Maintain product quality files including design history and technical files.
• Track and close CAPAs, Nonconformances and Post Market Surveillance.
• Assist with external audits by customers and FDA.
• Assist with quality inspection of products and components.
• Lead or facilitate root cause analyses as needed.
• Gather data for regulatory, productivity and management review indicators.
• Conduct internal QMS audits and implement regulatory changes.
• Support changes to design specifications and change control processes.
• Support process control improvements and develop procedures.
• Deliver employee communication and training on QMS policies.

Skills

QMS experience

FDA regulations

MS Excel

PowerPoint

Analytical skills

Communication

Quality system audits

Education

Bachelor's degree in science or related field

Tools

Greenlight Guru

Job description

Description

Summary:

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.

What You Will Own:

• 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.

Requirements

What You Will Bring:

• 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
• Experience with Greenlight Guru is a plus.
• Strong analytical capabilities
• Excellent communication skills and clear writing

PHYSICAL REQUIREMENTS

Physical demands of this position include, but are not limited to sitting, standing, walking, climbing, kneeling, twisting, reaching, bending, lifting up to 40 pounds, carrying, pushing, pulling, dexterity of utilizing hands and fingers, ability to work in a manufacturing environment, ability to work onsite, seeing (close vision, distance vision, color vision, peripheral vision and depth perception), hearing and speaking.

What’s in it For You:

• Career Growth: progress and learn, stability, career development/path.
• Work Environment: autonomy, ownership, recognition of achievements, life-work balance (see what we did there), challenges.
• Culture: transparency of goals and plans, support, collaboration, trust, community, passion, growth mindset.
• Benefits: health, dental and vision insurance & more, unlimited discretionary time off (DTO), matching 401K, flexibility (i.e. work day start and end times).
• Compensation: fairness, timeliness, compensation system.

We are Molekule and we’re changing air purification. Molekule was created with a goal of using the power of science to eliminate indoor air pollution around the world. Our vision is to change the world from the indoors out by improving the safety and health of the places where we live, conduct business, learn, heal and connect. It’s a lofty goal, but that's why we need you!

Molekule Values –

Making Life Easy For Someone Else

"For our colleagues, for our customers, and for those who don't have equitable access."

Say The Hard Thing

"We solve problems with empathy and honesty."

Trust The Data

"We are guided by science and make decision based on the numbers, even if it means changing our opinion."

Make The Invisible Visible

"We reveal and address inefficient and inequitable dynamics at work and in the world."

Push For 1% More

"We have a growth mindset and push for positive change every day."

Act As Community

"We face challenges together. We celebrate victories together. We share skills together."

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 unless its State mandated.

Applicants with disabilities may e-mail [e-mail], to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time.