Head of Quality Management

Job Description:

Job Overview

We are looking for an experienced leader of quality management to help us take a unique cardiovascular monitoring system to market. You will be responsible for all aspects of the quality management system and ensure that we are compliant with all appropriate regulations, while empowering Casana to be fast and nimble. You must be a clear communicator, able to work independently, thrive in a startup environment, and be open to taking on new responsibilities. You will serve as the foremost authority on quality standards at Casana, driving alignment across various teams. This position is preferably based in Rochester, NY or Boston, MA, but can be remote.

Key Responsibilities

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS).
• Foster a culture of quality, ensuring that all teams understand and are aligned with the company's quality goals.
• Works closely with manufacturing, engineering, and product team members to ensure requirements, testing, standard operating procedures, and other controls are correctly structured to support each team.
• Serve as the primary liaison for external compliance audits, ensuring that all requirements are met and issues addressed promptly.
• Measure success through the effectiveness of the QMS implementation and garner feedback from cross-functional teams to continually drive improvements.
• Submit, lead, and facilitate product registrations, design change notifications, and applicable renewals as required.
• Other responsibilities as needed. 

Required Skills and Experience 

• Bachelor’s Degree required or requisite experience
• Minimum 10 years of experience in an organization manufacturing Class II FDA-regulated medical devices
• In-depth knowledge of 21 CFR Part 11, ISO 13485, ISO 14971, and other applicable standards and regulations
• Experience in managing post-market surveillance, CAPA, nonconformance, and change control
• Self-starter; organized, recognizes next steps and pursues logical paths to achieve results without continuous oversight
• Ability to delve into the specifics while maintaining a strategic vision

Desired Skills and Experience

• Knowledge of the Software Development Lifecycle (SDLC), software quality assurance, and regulatory standards within the medical device context.
• Knowledge of clinical trial/study process controls

About Casana

Casana is innovating healthcare delivery with a smart toilet seat that enables effortless, integrated, and consistent in-home health monitoring. The Heart Seat™ captures key clinical values, including FDA cleared heart rate, blood oxygenation, and future clinical measurements in development such as blood pressure.

The healthcare system has been searching for this actionable intelligence for decades, and it turns out, we were sitting on a great idea all along. 

Compensation

[$180k to $240k] Exact compensation may vary based on skills, experience and location. Our compensation consists of base salary and equity as well as a generous benefits package. 

Casana provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.