Medline

Medline

Sr. Quality Engineer

Chicago, Illinois · Senior

Sponsorship not specified$101k-$152kDetected 2 days ago
ExcelProcess ImprovementVendor ManagementFDA RegulatoryMedical DevicesProblem SolvingTime ManagementMicrosoft Office

About the role

  • 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.
  • 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.
  • Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
  • Act as Quality lead in the absence of Quality Management.
  • 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.
  • 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.

Requirements

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

Nice to have

  • Knowledge of advanced Six Sigma/Lean concepts.
  • We're dedicated to creating a Medline where everyone feels they belong and can grow their career.
  • Explore our Belonging page here.
  • Medline Industries, LP is an equal opportunity employer.

Skills

  • Position requires up to 15% travel.
  • Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
  • Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).

Compensation

  • $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.

Benefits

  • 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.
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This listing is sourced directly from Medline's careers page and normalized into a canonical job model.