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Quality Assurance Engineer

2 months ago

Denver, Colorado, United States Cubby Beds Full time
Job Overview

About Cubby Beds

Cubby Beds is an innovative startup dedicated to creating smart beds designed for individuals with cognitive challenges such as Epilepsy, Cerebral Palsy, Dementia, and Autism. Our goal is to enhance the quality of life for special needs children and their families through our groundbreaking products and strategic market approaches. Since our inception, we have positively impacted the lives of countless families, secured insurance coverage nationwide, achieved profitability, and built a dedicated team of 20 full-time employees in Denver, alongside numerous supporting contractors and partner factories.

As we move forward, our focus is on expanding our team, refining our products, enhancing our systems, and improving the customer experience to reach even more families in need of safe sleep solutions.

Your Role

Are you prepared to take on a crucial position that guarantees the utmost standards of quality and safety in the medical device sector? As a Quality Assurance Engineer, you will play a vital role in promoting excellence and innovation, ensuring that our Class I medical devices not only meet but exceed regulatory standards and customer expectations. Your main duties will involve monitoring and evaluating customer feedback and device performance data, identifying trends and potential issues that may surface post-launch. By analyzing customer insights, you will determine root causes, assist in implementing necessary corrective actions, and collaborate closely with cross-functional teams to elevate product quality. Your contributions will not only uphold the highest safety and efficacy standards but also foster continuous improvement in our design and manufacturing processes. This position demands a keen eye for detail, a proactive problem-solving approach, and a solid understanding of regulatory requirements, making it both challenging and immensely rewarding as you directly influence patient outcomes and advance healthcare technology.

Key Responsibilities

  • Conduct thorough root cause analyses to identify sources of customer feedback and complaints.
  • Gather and assess data from multiple sources to support investigations.
  • Review specific incidents or complaint investigation details comprehensively.
  • Engage with customers to understand their feedback and provide consistent updates.
  • Coordinate with internal departments such as Supply Chain, Support, Product, and Marketing to collect information and resolve issues.
  • Recommend and implement preventive measures to avert the recurrence of similar issues.
  • Prepare detailed reports on investigation findings, corrective actions, and preventive measures.
  • Ensure all documentation adheres to regulatory and company standards.
  • Monitor and report on key performance indicators related to complaint management.
  • Propose and execute enhancements to the complaint handling process.
  • Ensure all actions comply with relevant industry standards and regulations.

Qualifications

Essential Requirements

  • Bachelor's degree in Engineering, Life Sciences, or a related discipline.
  • A minimum of 1 year of experience in quality assurance within the medical device field.
  • Familiarity with ISO 13485, FDA regulations, and other pertinent standards.
  • Demonstrated attention to detail in all aspects of work.
  • Ensures accuracy and thoroughness in documentation and quality processes.
  • Possesses a solid understanding of regulatory requirements.
  • Communicates effectively with team members, customers, and partners.
  • Facilitates understanding and collaboration across departments.
  • Engages in a culture of continuous improvement and innovation.
  • Aware of risks to ensure patient safety and product quality.

Preferred Qualifications

  • Advanced degree in Engineering, Life Sciences, or a related field.
  • 2+ years of experience in quality assurance within the medical device industry.
  • Experience with Class I medical device products.
  • Background in consumer-facing products.
  • Experience in customer experience or customer service roles.

Benefits and Perks

  • Compensation: $80-95k hiring range, with an exciting OTE (On-Target Earnings) program to celebrate collective success in achieving company goals. The total compensation includes 85% base salary and 15% variable pay upon meeting targets, with additional accelerators for exceeding them.
  • Stock Options - Equity Ownership.
  • Comprehensive Health, Dental, and Vision Insurance (100% paid premiums for employees).
  • Unlimited PTO & Sick/Wellness Hours.
  • 12 paid holidays plus a paid volunteer day.
  • 401k plan.
  • Hybrid Work Model: In-office Monday-Wednesday, with optional remote work Thursday-Friday.
  • High-quality office equipment including Mac, standing desk, and accessories, along with a work-from-home stipend.
  • Paid parking.
  • Fully stocked kitchen and biweekly team lunches at our Denver headquarters.
  • Opportunities for growth within a startup committed to a life-changing mission.

Cubby Beds is dedicated to fostering 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.