Vice President - Quality and Regulatory

Job Description

Posted Friday, January 23, 2026 at 7:00 AM

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary:

The Vice President of Quality will develop and lead Forj Medical’s enterprise-wide global Quality strategy, ensuring compliance with applicable regulatory standards while driving operational excellence across the organization. This role is responsible for fostering a quality-focused culture throughout the entire organization. In addition, this role is pivotal in harmonizing quality systems post-integration and fostering a culture of continuous improvement to support patient safety and product integrity.

Job Duties and Responsibilities:

• Strategic leadership and Integration:
• Define and execute the Quality vision aligned with Forj Medical’s business objectives and integration roadmap
• Serve as executive sponsor for Quality initiatives, including QMS harmonization and ERP integration
• Design and implement programs, policies and practices to ensure Quality Assurance and compliance
• Champion and embed a strong quality-focused culture, that matches our customer’s business and needs, throughout the organization
• Regulatory Compliance:
• Ensure adherence to FDA, ISO 13485, EU MDR, and other applicable regulatory standards
• Oversee compliance auditing programs to fulfill regulatory requirements
• Continuously monitor the regulatory landscape to identify laws and regulations that impact the company’s policies
• Culture, Engagement and Communication:
• Shape and sustain a cohesive values-driven culture across diverse operating environments
• Promote transparent communication and engagement strategies that reinforce organizational priorities
• Team Leadership and Development:
• Provide direct supervision and leadership to the Quality team, defining clear roles and reporting structures
• Facilitate cross-team collaboration and cultural alignment across teams and facilities
• Foster a high-performance, results-oriented culture and ensure continuous professional development of team members

Qualifications and Requirements:

Required:

• 15+ years of progressive Quality and/or Regulatory leadership experience, including at least 5 years in a global senior leadership role
• Proven track record of leading post-merger/acquisition Quality integration
• Proven ability to build a quality-focused culture and manage large teams
• Experience in a medical device CDMO or life sciences contract services organization
• Experience with customer engagement and communication, from project-level to executive (C-suite), with the ability to balance Forj business and customer success
• Demonstrated executive leadership capabilities, including advanced communication, stakeholder influence, and the ability to build and lead high-performing global teams
• Strong financial and P&L management skills, with the ability to align quality strategies with overall business objectives
• Ability to travel approximately 20–30% to domestic and international locations
• Minimum of a bachelor’s degree (master’s degree preferred)

Preferred:

• Multi-facility leadership experience
• Executive experience leading organizations with institutional ownership (e.g., Private Equity)
• Prior experience presenting to boards of directors and shareholders

Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

All positions are responsible for following applicable company policies and procedures as defined by their manager.

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to…