Senior Quality Manager - Inspection Readiness & Response Management

Job Summary

Job Description

MAJOR RESPONSIBILITIES:

• 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.
• Leads 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 particpate in policy setting activities.
• Oversee the execution to the resolution of all quality issues.
• Provides Leadership support during internal/external regulatory audits.
• Develop and maintain the enterprise inspection readiness program to ensure continuous compliance with FDA, EMA, ISO, and other applicable regulatory requirements.
• Lead regulatory inspection preparation activities, including mock inspections, readiness assessments, risk evaluations, and coaching of key personnel.
• Direct inspection response activities, including front-room and back-room operations, document management, response coordination, and executive communications.
• Partner with Quality, Manufacturing, Regulatory Affairs, and Operations leaders to identify compliance risks and strengthen quality system effectiveness.
• Lead post-inspection activities, including observation responses, remediation programs, CAPA execution, and effectiveness verification.
• Monitor regulatory trends and industry best practices to continuously improve organizational inspection readiness and compliance maturity.
• Management responsibilities include:
• --Typically, manages through multiple Managers and/or Supervisors
• --Oversee major projects/programs/outcomes;
• --Budget responsibility;
• --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.

MINIMUM JOB REQUIREMENTS:

Education:

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field. Equivalent level of experience also acceptable.

Certification / Licensure:

• None

Work Experience:

• At least 5 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 2 years of management experience.

Knowledge / Skills / Abilities:

• Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
• Proficiency in analyzing and reporting data and performing statistical analysis in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
• Advanced skill level in Microsoft Excel (for example: pivot tables and reporting, conditional formatting, tables, formulas, charting, etc.).
• Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS:

Work Experience:

• 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.

Knowledge / Skills / Abilities:

• None

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:

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. 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.