Mgr QA - Risk Management Process

Medline; Chicago (IL); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality and Regulatory leader in the Chicago area to oversee quality and regulatory compliance for assigned products and processes across lifecycle and distribution regions.

You will adapt departmental plans to address resource and operational challenges, collaborating with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction. Travel up to 25% may be required.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field, or relevant experience.
• At least 4 years of experience in medical device or drug combination product design/operation with design controls and risk management.
• Knowledge of QSR, GMP, ISO (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR).
• Advanced Excel skills and ability to analyze data to drive improvements.

Responsibilities

• Ensure quality and regulatory compliance across lifecycle and regions.
• Act as liaison with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction.
• Manage complaints and drive investigations to develop corrective actions.
• Identify and manage execution of continuous improvement projects.
• Assist in planning design, testing, inspection, and process validations to assure quality.
• Resolve quality issues to customer satisfaction in a timely manner.

Skills

Regulatory compliance

Excel proficiency

Project coordination

Education

Bachelor’s degree in Engineering/Science/Technical Field

Job description

Job Summary

Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges.

Job Description

MAJOR RESPONSIBILITIES

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during the investigation process.
• Identify and manage the execution of continuous improvement projects.
• Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.
• Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components.
• Ensure all quality issues are resolved to customer satisfaction, in a timely manner.
• Resolve issues relating to product or production quality by interfacing with internal and external customers.

Management responsibilities include

• Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments
• Day-to-day operations of a group of employees; May have limited budgetary responsibility and usually contributes to budgetary impact; 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, or relevant experience.
• Certification / Licensure: None
• Work Experience: At least 4 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).
• Knowledge / Skills / Abilities: Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.) Proficiency in analyzing and reporting data 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 level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS

• Education: None
• Certification / Licensure: None
• Work Experience: At least 2 years of supervisory/managerial experience preferred. 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: $116,000.00 - $174,000.00 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.

• 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.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes.

Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

To learn more about how Medline makes healthcare run better, visit www.medline.com.