Senior Quality Engineer - Respiratory

Medline Industries, LP•Northfield, IL

14d•$101,000 - $152,000

About The Position

Under minimal supervision, the Senior Quality Engineer independently sets basic quality standards for in-process work and leads efforts to develop methods for testing, sampling, and training. The role evaluates production processes, recommends improvements, qualifies and manages vendors, and generates and maintains Device Master Records (DMRs), product specifications, design control files, and CE technical files. The engineer manages process control, validation, improvement, testing, and inspection methods to ensure product quality and functionality. The role applies experimental design and statistical methods to evaluate variation and process changes, investigates defects and nonconformances, and leads corrective and preventive actions. It also provides quality expertise for product development, design controls, risk management, regulatory documentation, supplier quality, and product testing. The position requires a bachelor’s degree in a technical field and at least four years of experience in Quality or Engineering. It requires knowledge of applicable government and industry quality standards, strong independent project and problem-solving skills, cross-functional leadership, and advanced Microsoft Excel skills. The role requires up to 15% travel. The anticipated annual salary range is $101,000–$152,000; the role is bonus and/or incentive eligible. Medline offers a competitive total rewards package and continuing education and training. Benefits for employees working at least 30 hours per week on average include health insurance, life and disability insurance, 401(k) contributions, and paid time off. Benefits for employees working fewer than 30 hours per week include 401(k) contributions, paid time off, and access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.

Requirements

Bachelor’s degree in Engineering, Science, Math, or another related technical field.
At least 4 years of experience in Quality or Engineering.
Experience applying government and industry quality assurance codes and standards, such as 21 CFR 820, ISO 13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards.
Ability to accomplish goals with little or no supervision, complete objectives independently, and determine when escalation is necessary.
Time-management skills to prioritize, organize, and track details to meet deadlines across multiple projects.
Problem-solving ability to overcome obstacles and reach successful solutions through mathematical or systematic operations.
Experience leading a team to accomplish cross-functional goals.
Experience using Microsoft Office Suite products, including Word, Excel, PowerPoint, and Outlook.
Advanced Microsoft Excel skills, such as pivot tables and reporting, conditional formatting, tables, formulas, and charting.
Ability to travel up to 15%.

Nice To Haves

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.

Responsibilities

Manage development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection.
Design complex experiments to identify sources of variation affecting products and processes, and apply statistical process control methods to analyze data and evaluate processes and changes.
Design and perform experimental product testing and analysis to maintain quality and minimize defects and failure rates.
Generate and analyze reports and defective products to identify trends and lead corrective actions, using probability and statistical quality-control concepts to guide decisions.
Collaborate with supplier representatives to resolve quality problems, ensure corrective actions are implemented, contribute to supplier quality improvement programs, and lead supplier qualifications.
Provide quality expertise in product development, design control, risk management, and CE technical files.
Build product documentation, including Device Master Records, in compliance with applicable regulations.
Work with Regulatory Groups and suppliers on 510(k) submissions, letters to file, and related materials 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.
Review design documentation, vendor quality documents, and company quality records for compliance with stated requirements.
Lead investigations of product and process nonconformances and out-of-specification results, and develop effective corrective and preventive actions.
Train and coach team members and Medline employees on appropriate processes and best practices as needed.
Act as Quality lead in the absence of Quality Management.

Benefits

Health insurance (for employees working 30 or more hours per week on average)
Life insurance (for employees working 30 or more hours per week on average)
Disability insurance (for employees working 30 or more hours per week on average)
401(k) contributions
Paid time off
Access to the Employee Assistance Program for employees working fewer than 30 hours per week
Access to Employee Resource Groups for employees working fewer than 30 hours per week
Access to the Employee Service Corp for employees working fewer than 30 hours per week
Continuing education and training
Competitive total rewards package
Bonus and/or incentive eligibility