Medline Industries
Sr. Manager Regulatory Compliance, Supplier Quality
Medline Industries, Raleigh, North Carolina, United States, 27601
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.
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.
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
Interpret and execute policies for departments/projects and develops
Recommend and implement new policies or modifications to existing policies
Provide general guidelines and parameters for staff functioning
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 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.
Supplier Quality Manager • Raleigh, NC, US
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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.
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
Interpret and execute policies for departments/projects and develops
Recommend and implement new policies or modifications to existing policies
Provide general guidelines and parameters for staff functioning
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 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.
Supplier Quality Manager • Raleigh, NC, US
#J-18808-Ljbffr