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Quality ManagerCubby Beds • Denver, Colorado, United States
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Quality Manager

Cubby Beds
  • US
    Denver, Colorado, United States
  • US
    Denver, Colorado, United States
Postuler Maintenant

À propos

Join Our Team as a Quality Manager: Lead the Way in Medical Device Excellence!
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, been insurance covered in all 50 states, achieved profitability, and are building a growing team 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 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
Maintain the Quality Management System (QMS) in accordance with FDA regulations (21 CFR Part 820) and other applicable standards.Work with suppliers to resolve identified quality issues and improve product quality.Lead root cause analysis and implement corrective and preventive actions (CAPAs).Maintain and continually evolve an eQMS for primarily document control, training, and complaint handling functionality.Conduct risk assessments for product development and manufacturing processes.Collaborate with the design team to ensure thorough and accurate documentation.Curiosity and innovation are in our DNA. We expect every team member to use AI to enhance their work and advance our mission.
Here's what we're looking for
You will have at least
Bachelor's degree in engineering, life sciences, or a related field - or at least 2 additional years experience managing a QMS or similarMinimum 5 years in quality management within an FDA-regulated medical device environment.Experience with quality management systems (e.g., ISO 13485, FDA QSR 21 CFR Part 820) and associated tools or software.Strong attention to detail, organizational skills, and ability to track multiple projects simultaneously.Effective written and verbal communication skills to clearly document quality activities and collaborate with cross-functional teams.Accuracy and completeness in documentation, investigations, and quality processes.Clear communication skills with team members, suppliers, and regulatory bodies.Ability to thrive in a startup environment where not every system is mature and priorities shift.
We hope you also have
Certified Quality Auditor (CQA) or Certified Quality Manager (CQMgr) preferred but not required.Experience in consumer-facing products.Experience implementing or managing an eQMS platform.
To Apply: All applications must be submitted through the Job Openings section of the Cubby Beds Careers site
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: At Cubby, we reward great performance with clear, motivating compensation. We believe in aligning incentives and sharing wins.
Total Comp for this Role: $115,000-135,000This includes:
Base Salary: $104,000-123,000Performance Bonus: Up to 10% of your base salary if targets are hitStock Options - Equity OwnershipHealth, Dental, and Vision InsuranceUnlimited PTO & Sick/Wellness Hours12 paid holidays, a paid Volunteer Day and a Powder Day401k with a company matchHybrid Work Model: Monday-Wednesday in the office, optional work from home Thursday-FridayMac, standing desk, and high-end accessories at the office + a work-from-home stipend to purchase equipment needed for home officesPaid parkingAnnual staff retreatStocked kitchen and bimonthly team lunches in our beautiful Denver HQGrowth opportunities at a start-up with a life-changing mission
If you have the desire to take on a pivotal quality role in a high-growth org that also changes lives, we want to meet you! Interested? Apply now!
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. For data removal requests from our Applicant Tracking System, please email recruiting@cubbybeds.com.
This position will remain open until filled.
  • Denver, Colorado, United States

Compétences linguistiques

  • English
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