Quality Manager

Cubby Beds•Denver, CO

1d•Hybrid

About The Position

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.

Requirements

Bachelor's degree in engineering, life sciences, or a related field — or at least 2 additional years experience managing a QMS or similar
Minimum 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.

Nice To Haves

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.

Responsibilities

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).
Implement an eQMS for document control, training, and complaint handling.
Conduct risk assessments for product development and manufacturing processes.
Collaborate with the design team to ensure thorough and accurate documentation.

Benefits

Base Salary: $104,000-123,000
Performance Bonus: Up to 10% of your base salary if targets are hit
Stock Options - Equity Ownership
Health, Dental, and Vision Insurance
Unlimited PTO & Sick/Wellness Hours
12 paid holidays, a paid Volunteer Day and a Powder Day
401k with a company match
Hybrid Work Model: Monday-Wednesday in the office, optional work from home Thursday-Friday
Mac, standing desk, and high-end accessories at the office + a work-from-home stipend to purchase equipment needed for home offices
Paid parking
Annual staff retreat
Stocked kitchen and bimonthly team lunches in our beautiful Denver HQ
Growth opportunities at a start-up with a life-changing mission