Sr QA Manager - Urology

Job Summary

Position will be moving to the downtown Chicago location (Merchandise Mart) in March 2025.

JOB SUMMARY 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.

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 participate in policy setting activities. Oversee the execution to the resolution of all quality issues. Provides Leadership support during internal / external regulatory audits.
• Management responsibilities include : Typically, manages through multiple Managers and / or SupervisorsOversee 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.
• 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.

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 :

132,600.00 - $199,160.00 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. 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.

Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.

Salary : $132,600 - $199,160