Quality Assurance Manager - Operating Room

Medline; Chicago (IL); On-site; USD 115,000 - 174,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Manager to lead compliance and quality management efforts. This pivotal role involves ensuring adherence to regulatory standards, managing product quality, and driving continuous improvement initiatives. The ideal candidate will possess a strong background in medical devices or pharmaceuticals, with proven skills in project management and data analysis. Join a dynamic team dedicated to delivering high-quality products and enhancing customer satisfaction in a diverse and inclusive environment.

Benefits

Health Insurance

401(k) Contributions

Paid Time Off

Life and Disability Insurance

Qualifications

• 4+ years of experience in medical device or drug combination product platforms.
• Broad technical knowledge of relevant standards and regulations.

Responsibilities

• Manage quality and regulatory compliance for assigned products.
• Oversee continuous improvement projects and assist in product evaluations.

Skills

Quality Assurance

Regulatory Compliance

Project Management

Data Analysis

Microsoft Excel

Education

Bachelor’s degree in Engineering, Science, or 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

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.

Requirements:

Education

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

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 apivot table).

• Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).

Preferred Requirements:

Work Experience

• At least 2 years of supervisory/managerial experience.

• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

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:

$115,440.00 - $173,160.00 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.