Quality Assurance Specialist
Lakeland, FL
Operations – Quality Engineering /
Full-time /
On-site
"Best Places to Work 2021" -SF Business Times
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 QA Specialist to join our growing team. This individual will be responsible for quality assurance, field quality, product quality, reliability and compliance work streams. They will be a valuable member of the team working on process validation, calibration, maintenance, incoming inspection and quality control activities.
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: time off, stock options, matching 401K, flexibility (i.e.: work day start and end times).
- Compensation: fairness, timeliness, compensation system.
What you will own:
- Translate product & compliance requirements into detailed test plans and development schedules.
- Work with cross-functional teams to assess risks, understand coverage needs and priorities.
- Provide input & review of Molekule's AVL, BOMs, SOPs and WIs.
- Support and assist in maintaining FDA / medical device QMS (21 CFR 820 / ISO 13485.)
- Assist in maintaining chemical control procedures in Molekule's supply chain as well as a test lab to monitor chemical emissions from incoming parts and final systems.
- Apply project management skills towards the execution of improvement plans consisting of smaller projects all aimed at increasing work efficiency and generating accurate and practical metrics (Quality & Reliability Metrics, Planning Role, CAPA, Root Cause, etc).
What you bring to the team:
- Bachelor’s degree in science or related field.
- 3+ years’ Quality Assurance 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.
- Strong analytical capabilities.
- Successful experience in a manufacturing environment (domestic and international).
- Strong fundamentals in quality engineering (test planning, automation development, troubleshooting).
- Strong working knowledge of Process Flow, FMEA, Control Plan, PPAP, GR&R.
- Experience in problem solving tools: 8D, 5Why, Pareto, Data Analysis, etc.
- Knowledge of acceleration models for common failure mechanisms and stress types.
- Solid experience in test planning, performance testing, scalability/reliability testing, troubleshooting, debugging.
- Experience working effectively across teams, including product development, product management, customer operations, and field teams.
- Experience working and ensuring strong collaboration with global teams.
- Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications.
- Some travel required, including international.
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 peopleteam@molekule.com, to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time.
