Vice President - Quality and Regulatory

Forj Medical•Arden Hills, MN

About The Position

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.

Requirements

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)
Must be authorized to work in the United States.

Nice To Haves

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

Responsibilities

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
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
Shape and sustain a cohesive values-driven culture across diverse operating environments
Promote transparent communication and engagement strategies that reinforce organizational priorities
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