SVP Quality Systems

Regulatory Toolkit; Northfield Township (IL); On-site; USD 309,000 - 464,000; Full time

Job summary

Medline Industries, LP seeks a transformative leader to govern the global Quality Management System, post-market surveillance, and quality technology, ensuring compliant, data-enabled, and sustainable quality operations across sites and functions.

You will set strategy, governance, performance expectations, and organizational capability while partnering with Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, and business leadership to drive adoption, escalation, and

Qualifications

• Bachelor's degree in Engineering, Quality Assurance, Life Sciences, Regulatory Affairs, Business, or related field.
• Professional quality or regulatory certification preferred as applicable to the function.
• Extensive knowledge of FDA requirements, ISO 13485, EU MDR, and global quality/regulatory standards.

Responsibilities

• Provide executive leadership over the global QMS and ensure compliance with FDA, ISO, and global requirements.
• Partner with Global Process Owners to define, harmonize, govern, and improve common quality processes.
• Establish QMS governance, management review, metrics, escalation, and accountability across sites.

Skills

Executive leadership

Strategic planning

Stakeholder management

Risk management

Analytical thinking

Communication

Travel planning

Education

Bachelor's degree

Master’s degree (preferred)

Job description

Job Summary

Provide enterprise leadership for the global Quality Management System and its core processes, including post-market surveillance and quality technology, to ensure compliant, harmonized, data-enabled, and sustainable quality operations.

The role establishes functional strategy, governance, performance expectations, and organizational capability while partnering across Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership as relevant to the function. The leader is accountable for effective execution, timely escalation, and sustainable compliance with applicable requirements.

Job Description

MAJOR RESPONSIBILITIES

Global QMS Governance

• Provide executive leadership over the global Quality Management System, ensuring compliance with FDA regulations, ISO standards, and applicable global requirements.

• Identify and partner with Global Process Owners to define, harmonize, govern, and continuously improve common quality processes.

• Establish QMS governance, management review, metrics, escalation, and accountability across sites and business units.

Post-Market & Quality Technology

• Provide executive oversight for Post-Market Surveillance, including complaint handling, signal detection and trending, adverse event reporting, and integration of post-market data into risk management.

• Define and lead the quality technology strategy, including enterprise quality systems, quality data, analytics, AI, and automation.

• Ensure quality systems are selected, implemented, validated, maintained, and improved in alignment with business and regulatory needs.

Organizational Leadership

• Lead and develop leaders who own core QMS functions, ensuring consistent capability, resourcing, and accountability.

• Partner with Product Quality, Operations Quality, Regulatory Affairs, IT, Legal, and business leaders to drive adoption and sustainable execution.

• Promote a proactive, risk-based quality culture focused on product quality, patient safety, compliance, and operational effectiveness.

Management Responsibility

• Lead, organize, plan, direct, staff, coordinate, and communicate across senior leaders and teams responsible for the function to execute business plans and required organizational changes.

• Set performance standards, establish clear decision rights and accountability, monitor performance, develop talent, and maintain appropriate staffing and capabilities.

• Build an environment of open communication, collaboration, disciplined execution, and continuous improvement.

MINIMUM JOB REQUIREMENTS

Education

• Typically requires a Bachelor's degree in Engineering, Quality Assurance, Life Sciences, Regulatory Affairs, Business, or a related field.

Certification / Licensure

• Professional quality or regulatory certification preferred, as applicable to the function.

Work Experience

• At least 15 years of progressively responsible experience in Quality Assurance, Regulatory Affairs, Quality Engineering, or a related function within medical device, pharmaceutical, healthcare products, or another highly regulated industry.

• At least 10 years of progressively responsible people-leadership experience, including leading senior leaders and complex, multi-site or global organizations.

• At least 5 years of executive-level experience at the Vice President level or above with responsibility for enterprise outcomes, cross-functional execution, organizational capability, and succession planning.

Knowledge / Skills / Abilities

• Deep knowledge of applicable FDA requirements, ISO 13485, EU MDR, and other global quality and regulatory requirements relevant to the function.

• Executive leadership skills with demonstrated ability to set strategy, govern complex portfolios, allocate resources, and drive accountable execution.

• Strong business judgment and ability to balance compliance, product quality, patient safety, customer needs, and operational objectives.

• Excellent executive communication, influencing, negotiation, and stakeholder management skills.

• Demonstrated ability to build high-performing organizations and develop senior leaders.

• Strong analytical, risk-management, problem-solving, and decision-making capabilities.

• Position requires travel up to 50% for business purposes, including domestic and international travel.

PREFERRED JOB REQUIREMENTS

• Master’s degree in Engineering, Quality Management, Regulatory Affairs, Life Sciences, or Business preferred.

• Relevant professional certification and significant experience in a complex global healthcare products organization preferred.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$309,000.00 - $464,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.