Senior Engineer Quality

Medline Industries, Inc. in; Chicago (IL); On-site; USD 101,000 - 152,000; Full time

Job summary

Medline Industries, LP in Chicago seeks a Senior Engineer Quality (Project Management) to set baseline quality standards, develop testing methods, sampling and training, while leading vendor management and creating DMRs and design control files.

We require 4+ years in quality/engineering, strong knowledge of 21 CFR 820, ISO13485, and related standards; travel up to 15% is expected. Salary range is $101,000–$152,000 with bonus eligibility and comprehensive benefits.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• 4+ years of experience in Quality or Engineering.
• Experience with government/industry quality codes (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO) preferred.
• Ability to work with minimal supervision and drive objectives.
• Strong time management and multitasking skills.
• Proven problem solving and cross-functional collaboration ability.
• Experience leading a team and MS Office proficiency.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing and inspection.
• Design experiments and apply SPC to analyze data and guide decisions.
• Lead CAPA/SCAR actions and supplier quality improvements.
• Provide quality expertise in product development, design control, risk management, and CE files.
• Coordinate device master records and 510K submissions with regulatory and suppliers.
• Direct product testing with internal/external labs and ensure regulatory compliance.

Skills

Advanced Excel

Leadership / Team leading

Time management

Problem solving

MS Office Suite

Statistical methods / SPC

CAPA / SCAR knowledge

Travel up to 15%

Education

Bachelor's degree in Engineering, Science, Math or related field

Tools

Microsoft Excel

MS Office Suite tools

SPC tools

Job description

Senior Engineer Quality (Project Management)

Job Summary

Under minimal supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files.

Senior Engineer Quality (Project Management)

Job Summary

Under minimal supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files.

Job Description

Responsibilities:

• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
• Design complex experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
• Direct and collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
• Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
• Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
• Coordinate product testing with internal and external laboratories as required.
• Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
• Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
• May train and coach team members and Medline employees on appropriate processes and best practices.
• Act as Quality lead in the absence of Quality Management.

Requirements:

Education

• Bachelor's degree in Engineering, Science, Math or other related technical field.

Work Experience

• At least 4 years of experience in the Quality or Engineering.
• Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge /
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation is necessary.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Experience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations.
• Experience leading a team to accomplish cross-functional goals.
• Experience using MS Office Suite products(Word, Excel, PowerPoint, and Outlook).
• Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).
• Position requires up to 15% travel.

Preferred Qualifications:

• At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
• Knowledge of advanced Six Sigma/Lean concepts.

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:

$101,000.00 - $152,000.00 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.

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 pagehere .

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.