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, been insurance covered in all 50 states, achieved profitability, and built a team of 20 full time employees in Denver (nearly 100 roles including supporting contractors and our partner factories).

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 compensation listed above is inclusive of 85% base compensation + 15% variable pay when targets are met (we also have accelerators when we exceed).
• 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

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!

To apply: please click on this link and follow the application process on the Cubby Beds website. Thank you!

https://cubbybeds.teamtailor.com/jobs/4681199-quality-manager

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.