Quality Management System Specialist

Lakeland, FL - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

Full-time

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 Molekules 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. Were 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!

Were 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 activites.
Assist with external regulatory/quality audits by customers and FDA.
Assist with quality inspection of Molekules 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:

Bachelors 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.

Whats 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 were 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. Its a lofty goal but thats why we need you!

Molekule Values

Making Life Easy For Someone Else

For our colleagues for our customers and for those who dont 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 employees 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 to request and arrange for accommodations. If you need assistance to accommodate a disability you may request an accommodation at any time.

Required Experience:

Full-timeDescriptionSummary: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 Molekules technology destroys airborne pollutants (pathogens VOCs SOx NOx etc.) instead of trying to trap t...