SVP Quality Systems

Medline Industries, LP; Northfield (MN); On-site; USD 309,000 - 464,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Career development

Job summary

Medline Industries, LP in the United States invites a senior executive to 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 quality operations.

You will partner across Quality, Regulatory Affairs, Operations, R&D, Supply Chain, Legal, Commercial, and business leadership; set strategy, governance, and accountability; and lead through change to

Qualifications

• Bachelor's degree in engineering, quality assurance, life sciences, regulatory affairs, business, or related field.
• 15+ years of progressively responsible experience in QA, regulatory affairs, quality engineering, or related function in highly regulated industries.
• 10+ years of people leadership experience, including leading senior leaders and multi-site/global organizations.
• 5+ years of executive-level VP experience with enterprise outcomes, cross-functional execution, and succession planning.

Responsibilities

• Lead global QMS governance across sites and business units.
• Define and execute post-market surveillance and quality technology strategy.
• Partner with Quality, Regulatory Affairs, IT, Legal, and executives to drive adoption.
• Develop leaders and ensure staffing, capability, and accountability across the function.
• Set performance standards, monitor progress, and advance a risk-based quality culture.
• Ensure compliance with FDA, ISO 13485, EU MDR and global requirements.

Education

Bachelor's degree (Engineering)

Bachelor's degree (Quality Assurance)

Bachelor's degree (Life Sciences)

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.

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.

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.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.

Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes.

Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

To learn more about how Medline makes healthcare run better, visit www.medline.com.