Sr. Manager Regulatory Compliance, Supplier Quality

Job Summary

Responsible for leading the quality and compliance for the Supplier Quality Program (Audits and Supplier Quality). Set organizational priorities, oversee resource utilization and develop operational plans and policies.

Job Description

Responsibilities :

Monitor and maintain compliance with applicable (ex. QSR, GMP, ISO) pertaining to the applicable life cycle and regions of

distribution for the product.

Direct and manage complex, high-risk supplier audits and internal audits to evaluate Quality Management Systems (QMS) and

regulatory compliance for manufacturers, contract sterilizers, laboratories, and raw material suppliers.

Act as a senior liaison with Divisions, Suppliers, Manufacturing, and Operations leadership to ensure quality products, timely

delivery, and customer satisfaction.

Leads the process and team during investigations and identifying resolutions for issues relating to the audit program by interfacing

with Divisions, Suppliers, Manufacturing, and / or Operations.

Devise and implement continuous improvement initiatives, develop best practices, and participate in policy-setting activities to

enhance supplier quality globally.

Oversee the execution the audit plan and own all audit escalations.

Creates and oversees the supplier quality program and ensures all suppliers are held to appropriate rigor based on their risk

Provides Leadership support during internal / external regulatory audits.

Performs audits with their teammates and individually.

Management responsibilities include :

Typically, manages through multiple Managers and / or Supervisors

• Oversee major projects / programs / outcomes;
• Budget responsibility;

Responsible for ensuring the team has adequate training and is state of the art.

Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating

personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational

policies.

Qualifications :

Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field.

Work Experience

At least 7 years of experience related to the design / operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR / GMP / ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR). At least 3 years of management experience.

Preferred Qualifications :

At least 5 years of direct experience with recall management

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 :

$152,880.00 - $229,320.00 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 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

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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.