Vice President, Quality Systems

Vice President, Quality Systems

QMed Corporation

Location: Ft. Lauderdale, FL

Industry: Healthcare Distribution

Reports To: EVP Operations, dotted to CEO

Salary Range: Competitive bonus benefits Employee Stock Ownership Plan

About the Company

QMed Corporation is a medical-surgical, laboratory, dental, and animal health products wholesale distributor established in 1990. The company has transitioned to an Employee Stock Ownership Plan (ESOP) within the last four years, empowering employees with an ownership stake in the business. This shift reflects our commitment to fostering a culture of shared success, dedication, and long-term stability—ensuring that our team directly benefits from the company's growth and achievements.

Position Summary:

QMed Corporation is seeking an experienced and visionary Vice President, Quality Systems to lead our enterprise-wide quality strategy, compliance programs, and inspection operations. Reporting to the executive leadership team, this role will oversee the design, implementation, and continuous improvement of our Quality Management System (QMS) and ensure compliance with FDA and ISO regulatory standards. The VP will also manage a dedicated team of inspectors responsible for verifying that all incoming products and materials conform to internal specifications and industry quality standards, safeguarding the integrity of QMed’s supply chain and product offerings.

This role requires a hands-on, collaborative leader with deep experience in regulated industries and a passion for fostering a culture of operational excellence and quality accountability.

Key Responsibilities:

Quality Systems Leadership

• Develop and lead QMed’s Quality Management System (QMS), ensuring compliance with applicable standards (e.g., ISO9001, ISO13485, FDA 21 CFR Part 820).
• Act as the executive sponsor and subject matter expert for all quality and compliance initiatives.
• Lead strategic quality planning and integration of best practices across departments.
• Serve as the primary interface with regulatory agencies and certification bodies, including leadership of third-party and customer audits.

Inspection & Product Quality Oversight

• Direct and manage the Inspection team responsible for conducting detailed inspections of all incoming products and materials.
• Ensure inspection processes and acceptance criteria align with both internal quality requirements and recognized industry standards.
• Implement robust inspection protocols, training programs, and testing methodologies to consistently evaluate product quality.
• Drive improvements in supplier quality through data analysis, feedback, and collaboration.
• Monitor trends and escalate quality issues that pose a risk to compliance, safety, or performance.

Compliance & Continuous Improvement

• Lead internal audits, including QMS, product pedigree, and quality decision audits.
• Oversee the management and timely resolution of Corrective and Preventive Actions (CAPAs).
• Develop and manage metrics and QMS performance reports (weekly, monthly, quarterly).
• Guide cross-functional quality initiatives such as Failure Mode and Effects Analysis (FMEA), root cause investigations, and risk mitigation strategies.
• Maintain current licensing, regulatory documentation, and vendor insurance compliance.

Qualifications:

• Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or related field required; Master’s degree preferred.
• Minimum of 10 years of progressive quality leadership experience, with 7 years in FDA-regulated industries (e.g., medical devices, healthcare, life sciences).
• Proven experience managing and scaling inspection teams and quality control operations.
• Strong knowledge of ISO 9001/13485, FDA 21 CFR Part 820, and applicable industry standards.
• Experience with printing, paper conversion, or paper-making technologies is highly desirable.
• Skilled in Microsoft Office and QMS tools; strong data and reporting orientation.
• Excellent communication, leadership, and cross-functional collaboration skills.

Ideal Candidate Attributes:

• A low-maintenance, proactive leader who thrives in a hands-on, fast-paced environment.
• Committed to cultivating a culture of quality ownership, from leadership through frontline operations.
• Comfortable working across organizational boundaries to drive results and innovation.