Vice President - Quality and Regulatory jobs in United States
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Minnetronix Medical · 11 hours ago

Vice President - Quality and Regulatory

Forj Medical is a company that collaborates with over 100 medical device companies to bring innovative technologies to market. The Vice President of Quality will develop and lead the global Quality strategy, ensuring compliance with regulatory standards and fostering a quality-focused culture within the organization.

Health CareManufacturingMedical DeviceProduct Design

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

Qualification

Quality leadership experienceRegulatory compliance knowledgeMedical device experienceFinancial management skillsTeam leadershipStakeholder influenceCultural alignmentCommunication skills

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

Benefits

Health
Dental
Vision
401K plans
Time off programs
Annual bonus program

Company

Minnetronix Medical

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Minnetronix Medical develops, manufactures, and commercializes medical device technologies.

Funding

Current Stage
Growth Stage
Total Funding
$20M
Key Investors
Altaris Capital Partners
2025-10-08Acquired
2021-02-03Private Equity
2016-01-26Series Unknown· $20M

Leadership Team

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Jonathan Pierce
VP, Corporate Affairs
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Stan Crossett
VP Manufacturing
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Company data provided by crunchbase