{"id":1624616,"url":"https://alion.io/job/molekule-quality-management-system-specialist","title":"Quality Management System Specialist","company":{"id":171869,"name":"Molekule","domain":"molekule.com","url":"https://alion.io/company/molekule","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lakeland, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":109000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Excel","optional":false}],"status":"live","first_seen_at":"2026-09-30T18:28:50Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-28T14:38:48Z","board_verified":true,"closed_at":null,"days_open":27,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":27},"description":"Description\nSummary:\nMolekule 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.\nWe 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!\nWe’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.\nWhat You Will Own:\nOwn the electronic QMS tool, Greenlight Guru, to ensure ISO13485 and FDA QSR requirements are met.\nProvide compliance direction, investigate complaints and verify deficiencies are corrected.\nEnsure maintenance of all product quality files including design history and technical files.\nTrack, report and complete Corrective and Preventive Actions, Nonconformances and Post Market Surveillance/Vigilance activities.\nAssist with external regulatory/quality audits by customers and FDA.\nAssist with quality inspection of Molekule’s products and components.\nWhen necessary lead or facilitate Root Cause Analysis investigations\nGather data for activities and status regarding key regulatory, productivity and management review indicators\nAssist, conduct, and report routine internal Quality Management System (QMS) audits to ensure compliance.\nImplement procedural updates due to changes in regulations (FDA QSR, 13485, and other regulatory requirements)\nAssist with the evaluation of proposed design changes, specifications, and drawing releases as related to compliance requirements per the Change Control process.\nSupport process control improvement by creating new, or updating existing production processes and test procedures as required.\nExecute employee communication and training programs that focus on the elements of a companywide Q&R program.\nRequirements\nWhat You Will Bring:\nBachelor’s degree in science or related field\n3+ years’ Quality Management System experience; experience with Class II medical devices strongly preferred\nExpertise in FDA regulations, as well as demonstrated experience with interpreting and monitoring them\nProficient computer skills, especially with Microsoft Excel, PowerPoint and electronic QMS programs\nExperience with Greenlight Guru is a plus.\nStrong analytical capabilities\nExcellent communication skills and clear writing\nPHYSICAL REQUIREMENTS\nPhysical 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.\nWhat’s in it For You:\nCareer Growth: progress and learn, stability, career development/path.\nWork Environment: autonomy, ownership, recognition of achievements, life-work balance (see what we did there), challenges.\nCulture: transparency of goals and plans, support, collaboration, trust, community, passion, growth mindset.\nBenefits: health, dental and vision insurance & more, unlimited discretionary time off (DTO), matching 401K, flexibility (i.e. work day start and end times).\nCompensation: fairness, timeliness, compensation system.\nWe 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!\nMolekule Values -\nMaking Life Easy For Someone Else\n\"For our colleagues, for our customers, and for those who don't have equitable access.\"\nSay The Hard Thing\n\"We solve problems with empathy and honesty.\"\nTrust The Data\n\"We are guided by science and make decision based on the numbers, even if it means changing our opinion.\"\nMake The Invisible Visible\n\"We reveal and address inefficient and inequitable dynamics at work and in the world.\"\nPush For 1% More\n\"We have a growth mindset and push for positive change every day.\"\nAct As Community\n\"We face challenges together. We celebrate victories together. We share skills together.\"\nMolekule 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.\nApplicants with disabilities may e-mail , to request and arrange for accommodations. 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