Sr Manager of Manufacturing Quality

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Responsible for leading the quality and compliance for applicable products and processes for assigned department(s). Set organizational priorities, oversee resource utilization and develop operational plans and policies.

• Monitor and maintain compliance with applicable (ex. QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Act as liaison with the Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
• Devise and implement effective communication strategies with Divisions, Suppliers, Manufacturing, and/or Operations Executives and other internal and external Stakeholders.
• Lead the process and team during investigations and identifying resolutions for issues relating to product or production quality by interfacing with Divisions, Suppliers, Manufacturing, and/or Operations.
• Devise and implement continuous improvement initiatives, develop and share best practices, and participate in policy setting activities.
• Oversee the execution to the resolution of all quality issues.
• Provide Leadership support during internal/external regulatory audits.

• Typically manage through multiple Managers and/or Supervisors.
• Oversee major projects, programs, and outcomes.
• Budget responsibility.
• Interpret and execute policies for departments/projects and develop 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, and ensuring consistent application of organizational policies.

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

• At least 5 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, and working in compliance with QSR/GMP/ISO requirements or other regulated industries (21
  
  CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• At least 2 years of management experience.
• Knowledge and depth of technical knowledge of relevant standards and regulations (21
  
  CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR, etc.).
• Proficiency in analyzing and reporting data and performing statistical analysis to identify issues, trends, or exceptions to drive improvement.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
• Advanced skill level in Microsoft Excel (e.g., pivot tables, reporting, conditional formatting, tables, formulas, charting).
• Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

• At least 4 years of managerial experience preferred.
• At least 6 years of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.

The Anticipated Salary Range For This Position
$ - $ 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 . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions 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.