Senior Quality Engineer - Respiratory

Medline Industries, Inc. in; Northfield Township (IL); Vor Ort; USD 101.000 - 152.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) contributions

Paid time off

Zusammenfassung

Medline Industries, LP is seeking an experienced Quality Engineer to set basic quality standards and lead development of testing, sampling and training methods. You will evaluate production processes, recommend improvements, manage vendor qualifications, and maintain DMRs, product specs, and design control files.

The role requires building CE technical files, coordinating with Regulatory and Suppliers, and driving CAPA for continuous quality improvement. Travel up to 15% is possible.

Qualifikationen

• Bachelor's degree in Engineering, Science, Math or other related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience with government/industry QA codes (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).
• Ability to work independently with minimal supervision and escalate when needed.
• Strong time management to juggle multiple projects.

Aufgaben

• Develop and implement methods and procedures for process control, validation, improvement, testing, and inspection.
• Design experiments to understand variation in products and processes.
• Apply SPC to analyze data and steer process changes.
• Perform product testing and analysis to maintain quality and minimize defects.
• Lead supplier qualifications and CAPA/SCAR activities.
• Coordinate product testing with internal and external labs as required.
• Ensure compliance with domestic and international regulations for product lines.
• Lead investigations of non-conformances and drive corrective actions.

Kenntnisse

Quality engineering

Statistical analysis

MS Office (Excel)

Project leadership

Time management

Ausbildung

Bachelor's degree in Engineering/Science/Math

Tools

MS Office

Excel (Advanced)

Pivot tables

Jobbeschreibung

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.

MAJOR 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.

MINIMUM JOB REQUIREMENTS

• Education: Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field.
• Certification / Licensure: None
• Work Experience: At least 4 years of experience in 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 / Skills / Abilities: 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 JOB REQUIREMENTS

• Education: None
• Certification / Licensure: None
• Work Experience: At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
• Knowledge / Skills / Abilities: 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.

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.

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.

If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

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.