Senior QA Engineer – Medical Device Process & CAPA Lead

Medline Industries, Inc.; Town of Hartland (WI); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP, is seeking a quality professional to set basic quality standards for in-process and lead methods testing, sampling and training. The role covers process control, validation, supplier quality, and regulatory documentation including 510K and CE files.

Responsibilities include designing experiments, applying SPC, and driving CAPA actions while interacting with internal teams and suppliers. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• 4+ years of quality or engineering experience.
• Experience with quality codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210/211, ANSI/AAMI/ISO).

Responsibilities

• Develop and implement methods for process control, validation, testing and inspection.
• Design experiments; apply SPC and analyze data to drive improvements.
• Lead supplier quality programs and CAPA investigations.
• Create and maintain design documentation and CE/510K filings as required.
• Mentor team members and act as Quality lead when needed.

Skills

Quality Assurance

SPC

CAPA

Vendor Management

MS Excel

Cross-functional Leadership

Education

Bachelor’s degree in Engineering/Science

Tools

MS Office

Job description

Medline Industries, LP, is seeking a quality professional to set basic quality standards for in-process and lead methods testing, sampling and training. The role covers process control, validation, supplier quality, and regulatory documentation including 510K and CE files.

Responsibilities include designing experiments, applying SPC, and driving CAPA actions while interacting with internal teams and suppliers. Travel up to 15% may be required.