We are looking for a Head of Quality to lead and strengthen our Quality Management System (QMS) and quality operations. This role is ideal for someone who enjoys building processes, ensuring compliance, and working closely with engineering and operations teams to support the development and delivery of high-quality medical devices.
This is a hands-on leadership position where you'll help establish quality processes, maintain regulatory compliance, and ensure products are developed and released following industry standards.
Key Responsibilities:
- Lead and maintain the company's Quality Management System (QMS), including SOPs, document control, training records, templates, and quality documentation.
- Support compliance with FDA Quality System Regulation (21 CFR Part 820/QMSR) and ISO 13485 requirements.
- Manage design assurance activities, including design controls, risk management, verification and validation documentation, and design history files (DHF).
- Ensure quality procedures are followed throughout product development and manufacturing.
- Develop and manage employee training programs and maintain training records.
- Support training for employees involved in clinical studies and product handling.
- Oversee quality processes such as incoming inspections, supplier quality records, equipment calibration, nonconformance tracking, product release documentation, installation records, and service documentation.
- Work closely with engineering and cross-functional teams to ensure product documentation and quality records are complete and accurate.
- Prepare the organization for internal and external quality audits.
Qualifications:
- 3+ years of experience in Quality Assurance, Quality Systems, Design Assurance, or Quality Operations within the medical device industry.
- Experience developing or improving a Quality Management System, preferably in a startup or growing medical device company.
- Knowledge of FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, design controls, document control, supplier quality, CAPA, nonconformance management, and product release processes.
- Understanding of engineering documentation, product verification and validation, and risk management.
- Strong organizational, communication, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.
The ideal candidate is someone who:
- Takes ownership and follows through on responsibilities.
- Has strong attention to detail and a quality-first mindset.
- Communicates effectively with cross-functional teams.
- Enjoys improving processes and building efficient systems.
- Thrives in a collaborative and growing environment.
- Is motivated to contribute to innovative medical technology.
Pay: $150,000.00 - $180,000.00 per year
Benefits:
Work Location: Hybrid remote in Cambridge, MA 02142
