Sr Engineer Quality- Advanced Wound Care

Regulatory Jobs; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Job summary

Regulatory Jobs seeks a Quality/Engineering professional to independently set basic quality standards for in-process activities and lead efforts to develop testing, sampling, and training methods. You will evaluate production processes, drive improvements, qualify suppliers, and maintain DMRs, product specs, and CE tech files.

Responsibilities include CAPA, supplier qualifications, and 510K coordination. The role requires a Bachelor’s degree in a technical field and 4+ years in quality or

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience applying 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).

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, testing, and inspection.
• Design experiments to understand variation sources and apply SPC to evaluate processes.
• Design and perform tests to maintain quality and minimize defects; generate reports; apply probability concepts.
• Collaborate with suppliers on quality issues; implement CAPA; lead supplier qualifications.
• Provide quality expertise in development, design controls, risk management, and CE files; coordinate 510K submissions.
• Ensure compliance with domestic and international regulations; review design documentation and vendor quality records.
• Lead investigations of non-conformances and CAPA actions.
• Train and coach team members and Medline staff on processes.
• Serve as quality lead in the absence of the Quality Management function.

Skills

Quality Engineering

CAPA

Supplier Quality

SPC

MS Excel

Travel up to 15%

Education

Bachelor’s degree in Engineering, Science, Math or related technical field

Job description

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

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 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 page here.

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.