Quality Manager

Cubby Beds

Quality Manager ensuring excellence in medical device products at Cubby Beds. Leading QMS management and collaboration for FDA regulations and safety standards.

Posted 4/28/2026full-timeDenver • Colorado • 🇺🇸 United StatesMid-LevelSenior💰 $104,000 - $123,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System (QMS)root cause analysiscorrective and preventive actions (CAPAs)risk assessmentsdocument controltrainingcomplaint handlingISO 13485FDA QSR 21 CFR Part 820quality management

Soft Skills

attention to detailorganizational skillseffective communicationcollaborationcuriosityinnovationability to track multiple projectsaccuracycompletenessadaptability