Quality Management System Specialist

About the role

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.

Responsibilities

• 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

• 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

• 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.

Benefits

• Health, dental and vision insurance & more.
• Unlimited discretionary time off (DTO).
• Matching 401K.
• Flexibility (i.e. work day start and end times).

Culture and 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