VP Manufacturing Quality (Devices)

Medline Industries, LP; Northfield (MN); On-site; USD 234,000 - 351,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Director of Quality Assurance to oversee QA functions across divisions, ensuring proper controls, staffing, and regulatory compliance. The role involves directing QA for new product development and supplier qualification, mentoring staff, and coordinating with Corporate Quality and division leadership.

You will ensure alignment with FDA, EU MDR and cGMP standards, build cross-functional relationships, and maintain robust training programs.

Qualifications

• Bachelor’s degree required.
• 7+ years of QA related experience in a business environment.
• At least 5 years of experience managing people, including hiring, developing, motivating and directing staff.

Responsibilities

• Oversee, lead and set strategic direction for the assigned divisions’ QA functions.
• Coordinate with Corporate Quality and division leadership to ensure adherence to FDA, MDR and other applicable requirements/cGMP’s.
• Develop and mentor staff through onboarding, training and performance management; maintain morale and ensure staffing with required competencies.
• Facilitate communication between QA Directors, Managers and Specialists and their divisional teams.
• Direct quality efforts for new product development and supplier qualification.
• Ensure communication between related functions, and meet project timelines and objectives.
• Develop training programs and approve process and procedural changes.
• Ensure systems support a smooth process for new products and services and outstanding customer service.

Job description

Job Summary

Oversee and lead Quality Assurance functions for assigned divisions. Ensure proper controls are in place, resources are appropriate and qualified for their roles, and that the assigned product divisions as well as the Quality organization are compliant.

MAJOR RESPONSIBILITIES

• Oversee, lead and set strategic direction for the assigned divisions’ QA functions.
• Work with and coordinate with Corporate Quality as well as with division leadership to assure adherence to US FDA, EU MDR and other applicable requirements/cGMP’s.
• Develop and mentor staff through on-boarding, open communication, training and development opportunities and performance management processes; build and maintain employee morale and motivation; ensure the team is appropriately staffed with required competencies.
• Facilitate communication between Quality Assurance Directors, Managers and Specialists and their respective divisional personnel.
• Direct quality efforts for new product development, new supplier qualification.
• Assure appropriate communication between all related functions, assure project timelines and objectives are met.
• Develop training programs, approve process and procedural changes.
• Ensure proper systems are in place to facilitate a smooth and efficient process for new products and services.
• Assure all internal and external customers receive outstanding service from the department.
• Travel as necessary to facilitate communications with external customers and vendors. (10% travel minimum)

MINIMUM JOB REQUIREMENTS

• Education: Bachelor’s degree.
• Certification / Licensure: None
• Work Experience: At least 7 years of QA related experience in a business environment.
• At least 5 years of experience managing people, including hiring, developing, motivating and directing people as they work.
• Knowledge / Skills / Abilities: Intermediate skill level in relevant computer programs.
• Willing to travel up to 20% of the time for business purposes (within state and out of state).
• Knowledge of Quality Assurance practices in regulated industry (Device, Pharma, Personal Care or Food).

PREFERRED JOB REQUIREMENTS

PREFERRED JOB REQUIREMENTS: None

BENEFITS & COMPENSATION

• The anticipated salary range for this position: $234,000.00 - $351,000.00 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.

COMPANY CULTURE & EEO STATEMENTS

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.

ABOUT THE COMPANY

Medline Industries, LP 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.