Quality Manager
We’re Cubby Beds 👋
A fast-growing and high-impact startup that makes smart beds for people with cognitive conditions like Epilepsy, Cerebral Palsy, Dementia and Autism. Our mission is to improve the lives of special needs kids and their families through our innovative products and go to market strategies. Since launch, we have changed the lives of thousands of families, secured insurance coverage in all 50 states, achieved profitability, and built a team of 20 in our Denver HQ.
The next stage of the business is all about scaling our team, product, systems, and customer journey to help thousands more families get the safe sleep they deserve.
This is where you come in
Are you ready to take on a pivotal role that ensures the highest standards of quality and safety in the medical device industry? As our Quality Manager, you will be at the forefront of driving excellence and innovation, ensuring that our Class I medical devices exceed regulatory requirements and customer expectations. You'll collaborate in implementing and maintaining a robust Quality Management System (QMS), conducting thorough risk assessments, and spearheading both internal and external audits. Your expertise will help to guide the development team through design controls, while your collaborative spirit will foster strong relationships with suppliers and stakeholders. With a focus on continuous improvement, you'll lead investigations into quality issues, manage corrective and preventive actions (CAPAs), and ensure impeccable documentation practices. Join us and make a tangible impact on patient safety and product quality, all while advancing your career in a dynamic and rewarding environment.
Here’s what you’ll be doing
Implement and maintain the Quality Management System (QMS) in accordance with ISO 13485, FDA regulations (21 CFR Part 820), and other applicable standards and regulations.
Execute internal and external audits to ensure compliance with quality standards.
Collaborate with suppliers to resolve quality issues and improve product quality.
Lead investigations into quality issues and implement corrective and preventive actions (CAPAs).
Ensure proper documentation and record-keeping practices are followed for all quality-related activities.
Help to ensure all staff are knowledgeable about quality policies and procedures.
Maintain control over quality documents, ensuring they are current, accurate, and readily accessible.
Conduct risk assessments and implement risk management strategies throughout the product lifecycle.
Manage customer feedback, complaints and where necessary MDRs related to product quality.
Ensure design control processes are implemented and maintained throughout the product development lifecycle.
Here’s what we’re looking for
You will have at least
Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
Minimum of 5 years of experience in quality management within the medical device industry.
Strong knowledge of ISO 13485, FDA regulations, and other relevant standards.
Experience with design control processes and requirements.
Excellent problem-solving skills and attention to detail.
Effective communication and leadership abilities.
Ensures accuracy and completeness in documentation and quality processes.
Demonstrates a strong understanding of regulatory requirements.
Communicates clearly and effectively with team members, suppliers, and regulatory bodies.
Facilitates understanding and collaboration across departments.
Encourages a culture of continuous improvement and innovation.
Monitors and evaluates risks to ensure patient safety and product quality.
Utilizes data and metrics to drive decision-making and quality improvements.
We hope you also have
Advanced degree in Engineering, Life Sciences, or a related field preferred.
Certification in quality management (e.g., ASQ CQE, CQA) preferred
Experience in consumer facing products is preferred
Don’t feel like you have all of the qualifications?
The description above indicates our current vision for the role. You could be a viable candidate even if you don't fit everything we've described above and may also have important skills we haven't thought of. If that's you - even if you’re unsure - we encourage you to apply and help us get to know you.
Benefits & Perks✨
Compensation: $100-120k hiring range - Cubby offers an exciting OTE (On-Target Earnings) program to motivate and celebrate collective success in achieving company goals. The total cash compensation range listed above is inclusive of base pay & target variable pay. The target variable pay for this role is 15% of the base salary.
Stock Options - Equity Ownership
Health, Dental, and Vision Insurance (100% paid premiums for employees)
Unlimited PTO & Sick/Wellness Hours
12 paid holidays + a paid volunteer day
401k administration (company match coming soon!)
Hybrid Work Model: Monday-Wednesday in the office, optional work from home Thursday-Friday
Mac, standing desk, and high-end accessories at the office
Paid parking
Fully stocked kitchen and biweekly team lunches in our beautiful Denver HQ
Growth opportunities at a start-up with a life-changing mission
Cubby Beds is committed to creating a diverse environment and is proud to be an equal-opportunity-employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Cubby Beds is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
This position will remain open until filled.
- Department
- Operations
- Locations
- Denver HQ
- Remote status
- Hybrid Remote
Denver HQ
10 Ways Cubby Stands Out
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Mission Driven
We believe in solving problems with purpose. And healthcare, at 20% of our country's GDP, is an impactful place to do so. Our products affect not just our patients' lives but the entire ecosystem around them. Working here, you’ll start to understand this complex web - and be a part of improving it.
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Risk/Reward Timing
We have product-market fit. And the sales + reviews to prove it. We’re scrambling to build the team and infrastructure to keep up with demand. With less than 20 team members, there’s still equity and career-defining responsibility to hand out.
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Solo Founded, Mostly Bootstrapped & Profitable
This gives us control over the pace and direction of our mission. It also enables us to give more equity so that our employees can be owners in our success and bought into the long term vision.
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Technology First
In an industry that still sends faxes, the bar is very low. You’ll make things feel magical by applying modern tools and friendly design to dusty outdated practices.
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High Standard Hiring
We strongly prefer 1 great hire over 3 average fits and will give you the comp, responsibility, and growth opportunity to flourish.
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Transparency
Everyone has full access to company financials, state of the company and the executive team + their network. Only by seeing the full business can you make the right decisions for the business.
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Set Yourself Up To Be A Founder
Come learn, make mistakes (on our dime), and grow your career so that in a few years, you can launch your own thing. But only if you want to… with this team and mission, you may end up not wanting to leave! :)
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Denver Based But Remote First
We think it’s a competitive advantage to work together, especially in a place as beautiful as our downtown Denver office. Our in-person culture is special and allows us to collaborate and innovate together. The most valuable relationships aren't built over zoom but instead over walks, whiteboard jams, and impromptu drinks/meals. Life at Cubby is rich of energy and fun.
With that being said, we’re remote first in our communications and decision making so everything is visible and everyone is included. We also provide unlimited PTO, WFH Fridays, and other flexibility to accommodate your life.
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We Care About Each Other
We have open communication, mental wellness + volunteer days, and a grassroots culture that’s reinforced by working on tough important problems with people who care just as much as you.
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Big Long Term Vision
The deeper we go, the more opportunities we see to improve and modernize the home health care industry. Let's chat about the 10 year vision in your interview!
We are on a mission to redefine healthcare in the home for people with cognitive conditions and special needs. Join a team committed to helping thousands of families get the safe sleep they deserve.
Quality Manager
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