Quality Assurance Manager
1 month ago
Cubby Beds is a fast-growing startup that develops innovative smart beds for individuals with cognitive conditions. Our mission is to improve the lives of special needs individuals and their families through our products and go-to-market strategies.
Job DescriptionWe're seeking a Quality Manager to drive excellence and innovation in our medical device industry. As a key member of our team, you will be responsible for ensuring the highest standards of quality and safety in our Class I medical devices. Your expertise will help us exceed regulatory requirements and customer expectations.
Key Responsibilities- Implement and maintain a robust Quality Management System (QMS) in accordance with ISO 13485 and FDA 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 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.
- 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.
- Advanced degree in Engineering, Life Sciences, or a related field.
- Certification in quality management (e.g., ASQ CQE, CQA).
- Experience in consumer-facing products.
- Compensation: $100-120k hiring range.
- 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.
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