Sr Engineer Quality

Medline Industries, LP • Chicago, IL

47d • $101,000 - $152,000

About The Position

Under minimal supervision, the Sr Engineer Quality independently sets basic quality standards for in-process operations and leads efforts to develop testing, sampling, and training methods. 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 position leads process control, validation, improvement, testing, and inspection activities; designs experiments and applies statistical methods to analyze process variation; and conducts product testing to maintain quality and reduce defects and failures. It also leads supplier quality activities, supports product development and design control, prepares and reviews regulatory documentation, coordinates testing, ensures regulatory compliance, and leads investigations and corrective and preventive actions. The role may train and coach employees and serves as Quality lead when Quality Management is absent.

The position requires a bachelor’s degree in a related technical field and at least four years of Quality or Engineering experience. Up to 15% travel is required. The anticipated annual salary range is $101,000–$152,000, with the role eligible for bonus and/or incentive compensation. Medline offers a competitive total rewards package, continuing education and training, and benefits that vary based on average weekly hours.

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 develop ways 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 experience, including overcoming obstacles and reaching 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 evaluate processes and changes.
• Design and perform experimental product testing and analysis to maintain quality and minimize defects and failures.
• 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 on quality problems, ensure effective CAPA and SCAR actions, contribute to supplier quality improvement programs, and lead supplier qualifications.
• Provide Quality expertise in Product Development, Design Control activities, 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 510K submissions, letters to file, and related needs.
• 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 non-conformances and out-of-specification results, and develop effective corrective and preventive actions.
• 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.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance for employees working an average of 30 or more hours per week.
• Life insurance for employees working an average of 30 or more hours per week.
• Disability benefits for employees working an average of 30 or more hours per week.
• 401(k) contributions.
• Paid time off.
• Access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp for employees working less than 30 hours per week.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior