Senior Medical Device Quality Engineer SPC, CAPA & CE Files

Medline Industries, LP; Town of Hartland (NY); 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 in the United States seeks a quality professional to set basic in-process quality standards and lead testing, sampling and training initiatives. You will evaluate production processes and ensure compliance with applicable quality requirements.

You will design experiments, apply Statistical Process Control, drive CAPA/SCAR actions, manage supplier quality, and build documentation for design controls, product specs and regulatory submissions as needed.

Qualifications

• Bachelor's degree in engineering/science/math or related field.
• Experience in quality or engineering roles (min 4 years).
• Knowledge of government/industry QA codes and standards (21 CFR 820, ISO13485).

Responsibilities

• Set and maintain basic in-process quality standards and lead testing, sampling and training efforts.
• Design experiments to understand variation and apply SPC to evaluate processes.
• Lead CAPA/SCAR investigations and collaborate with suppliers on corrective actions.
• Develop and maintain design control files, device master records and regulatory documentation.

Skills

Statistical Process Control

CAPA

Supplier Quality

Design of Experiments

Leadership

Education

Bachelor's degree in Engineering, Science, Math or related field

Tools

Microsoft Excel

MS Office Suite

Job description

Medline Industries, LP in the United States seeks a quality professional to set basic in-process quality standards and lead testing, sampling and training initiatives. You will evaluate production processes and ensure compliance with applicable quality requirements.

You will design experiments, apply Statistical Process Control, drive CAPA/SCAR actions, manage supplier quality, and build documentation for design controls, product specs and regulatory submissions as needed.