Senior Quality Engineer — Process Control & CAPA Leader

Medline Industries, LP; United States; 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 Engineer to set basic in-process quality standards and lead method development for testing, sampling and training. You will evaluate production processes, qualify vendors, and generate essential documentation including DMRs and regulatory files.

Under minimal supervision, you will design experiments, apply statistical process control, and drive CAPA/SCAR actions with supplier teams while maintaining compliance with regulations and quality systems.

Qualifications

• Bachelor's degree in a technical field is required.
• Minimum 4 years in Quality or Engineering.
• Experience with government/industry QA codes and standards (e.g. 21 CFR 820, ISO13485).
• Ability to work with minimal supervision and meet deadlines.

Responsibilities

• Develop and implement methods for process control, validation and inspection.
• Design experiments to understand variation sources.
• Apply SPC to analyze data and guide changes.
• Lead supplier qualifications and CAPA/SCAR activities.
• Prepare design documentation and 510K submissions as needed.

Skills

Quality engineering

SPC

CAPA/SCAR

Cross-functional collaboration

MS Office

Education

Bachelor's degree in Engineering/Science/Math

Tools

MS Office

Advanced Excel

Job description

Medline Industries, LP is seeking a Quality Engineer to set basic in-process quality standards and lead method development for testing, sampling and training. You will evaluate production processes, qualify vendors, and generate essential documentation including DMRs and regulatory files.

Under minimal supervision, you will design experiments, apply statistical process control, and drive CAPA/SCAR actions with supplier teams while maintaining compliance with regulations and quality systems.