Quality Management System Specialist

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.

• Own the electronic QMS tool, Greenlight Guru, to ensure ISO
  13485 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 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 company wide Q&R program.

• 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 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.

• 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.

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…