Quality Manager

Medline Industries, LP; Northfield (MN); 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 seeks a quality and regulatory leader to manage quality and compliance for assigned department(s), adapting plans to address resource and operational challenges.

You will collaborate with divisions, suppliers, manufacturing and operations to ensure quality products and customer satisfaction; oversee complaints, drive continuous improvement, and support design, testing, inspections and validations to uphold QSR, GMP, ISO requirements.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 4+ years of experience designing/operating medical device or drug product platforms with compliance.
• Broad knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDR and related standards.
• Strong data analysis to identify issues and drive improvements.
• Advanced Microsoft Excel skills (PivotTables, data analysis, etc.).

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations.
• Liaise with Divisions, Suppliers, Manufacturing, and Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during investigations.
• Identify and manage execution of continuous improvement projects.
• Assist in planning design, testing, inspection, and validations to assure quality products or components.
• Ensure quality issues are resolved to customer satisfaction in a timely manner.
• Interface with internal and external customers to resolve issues.

Skills

Regulatory compliance

Data analysis

Advanced Excel

Project coordination

Education

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

Tools

Microsoft Excel

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.

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, or equivalent experience.
• 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.

Salary & Compensation

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.

Benefits

• 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.

Company Culture & Diversity

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.

Other Information

If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you. Introduce yourself to our recruiters and we’ll get in touch if there’s a role that seems like a good match. 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.