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# VP, Quality Assurance with a Medical Device Manufacturer – Minneapolis, MN


Role Overview for VP, Quality Assurance with a Medical Device Manufacturer – Minneapolis, MN
JRG Partners has been exclusively retained to lead the search for a transformative Vice President of Quality Assurance for a pioneering medical device manufacturer located in the vibrant hub of Minneapolis, MN. This is a career-defining opportunity for a strategic leader to shape the future of quality and compliance within a dynamic, growth-oriented organization committed to improving patient outcomes through innovative technology.
As the Vice President of Quality Assurance, you will be the principal architect and guardian of the company’s global quality vision. Reporting directly to the Chief Operating Officer, you will serve as a key member of the executive leadership team, providing strategic direction and hands-on oversight for all aspects of the Quality Management System (QMS). Your leadership will be instrumental in fostering a robust ‘culture of quality’ that permeates every facet of the organization, from initial product conception to post-market surveillance.
This role demands a visionary who can look beyond mere compliance to see quality as a competitive differentiator and a driver of business excellence. You will be responsible for ensuring that all products not only meet but exceed the most stringent global regulatory standards, including those set by the FDA, EU MDR, and other international bodies. You will lead a talented, multi-disciplinary team of quality professionals, inspiring them to achieve new levels of performance and operational efficiency. Your expertise will guide the company through complex regulatory landscapes, critical audits, and new product introductions, ensuring unwavering commitment to patient safety and product efficacy. This executive position is critical to the company’s long-term success, strategic growth, and reputation as a leader in the medical device industry.
Key Responsibilities of VP, Quality Assurance with a Medical Device Manufacturer – Minneapolis, MN
Strategic Leadership & Vision
Develop, articulate, and execute a comprehensive global quality and regulatory compliance strategy that aligns with the company’s overarching business objectives. Champion a proactive, world-class quality culture throughout the entire organization.
QMS Oversight
Assume ultimate ownership of the Quality Management System (QMS), ensuring its effectiveness, efficiency, and unwavering compliance with all applicable global standards, including FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485, and the EU Medical Device Regulation (MDR).
Regulatory Affairs & Compliance
Serve as the primary point of contact and company representative for all regulatory agencies, including the FDA, Notified Bodies, and other international health authorities. Expertly manage all regulatory inspections, audits, and submissions.
Team Development & Mentorship
Lead, mentor, and cultivate a high-performing, global Quality Assurance and Regulatory Affairs (QA/RA) team. Foster an environment of continuous learning, professional growth, and accountability.
Product Lifecycle Management
Provide robust quality and compliance oversight across the entire product lifecycle, including design controls, risk management (ISO 14971), validation and verification, manufacturing processes, sterilization, and labeling.
Post-Market Surveillance
Direct all post-market activities, including the management of complaint handling, Medical Device Reporting (MDRs), vigilance reporting, and post-market clinical follow-up (PMCF) to ensure ongoing product safety and performance.
CAPA & Continuous Improvement
Own and drive the effectiveness of the Corrective and Preventive Action (CAPA) system. Implement and champion continuous improvement initiatives using methodologies such as Lean, Six Sigma, and statistical process control to enhance product quality and process efficiency.
Supplier Quality Management
Develop, implement, and manage a rigorous supplier quality program, including supplier qualification, auditing, and performance monitoring to ensure the integrity of the supply chain.
Executive Collaboration & Reporting
Collaborate closely with R&D, Operations, Clinical, and Marketing to ensure quality objectives are integrated into all business activities. Establish and report on key quality performance indicators (KPIs) to the executive team and Board of Directors.
Budget & Resource Management
Develop and manage the annual budget for the Quality Assurance department, ensuring optimal allocation of resources to meet strategic goals and compliance requirements.
Requirements for the VP, Quality Assurance with a Medical Device Manufacturer – Minneapolis, MN
Educational Background
A Bachelor of Science (B.S.) degree in Engineering, Life Sciences, or a related technical field is required. A Master’s degree (M.S., M.B.A.) or Ph.D. is strongly preferred.
Executive Experience
A minimum of 15 years of progressive experience in Quality Assurance within the medical device industry, with at least 7-10 years in a senior leadership capacity (e.g., Director, Senior Director, or VP) managing a significant team.
Regulatory Expertise
Demonstrated, expert-level knowledge of global medical device regulations and standards, including extensive hands-on experience with FDA QSR, ISO 13485, EU MDR, and risk management (ISO 14971).
Device Experience
Proven experience with Class II and/or Class III medical devices is essential. Experience with devices involving software (SaMD), electronics, or sterile products is highly advantageous.
Audit & Inspection Leadership
A proven track record of successfully leading organizations through FDA inspections, Notified Body audits, and other regulatory assessments.
Leadership & Influence
Exceptional leadership, communication, and interpersonal skills with the ability to influence and build consensus across all levels of the organization, from the manufacturing floor to the boardroom.
Strategic & Analytical Acumen
A strategic mindset with the ability to analyze complex issues, make data-driven decisions, and translate high-level strategy into actionable plans.
Certifications
Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Regulatory Affairs Certification (RAC) are highly desirable.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent and offers a comprehensive and competitive compensation package, including:

Highly competitive base salary and an attractive executive-level annual bonus plan.
Meaningful long-term incentives, including stock options or restricted stock units (RSUs).
Comprehensive benefits package, including premium medical, dental, and vision insurance for you and your dependents.
A robust 401(k) retirement savings plan with a generous company match.
Substantial paid time off (PTO), paid holidays, and flexible work arrangements.
A comprehensive relocation assistance package for qualified candidates moving to the Minneapolis area.
Commitment to professional growth with support for continuing education, certifications, and industry conferences.
Access to executive wellness programs and other corporate perks designed to support a healthy work-life balance.

How to Apply
This is an exclusive, confidential search being conducted by JRG Partners. We are seeking a leader who is passionate about quality and patient safety and who is ready to make a significant impact on a growing organization. If you are a proven Quality Assurance executive with the experience and drive to excel in this critical role, we encourage you to apply.
To express your interest in this executive opportunity, please visit our Medical Device Executive Search practice area page to learn more about our expertise and to submit your application and resume for confidential review. All inquiries and applications will be handled with the utmost discretion.