Medical Device Quality Engineer — Process Control & CAPA

Medline; Howell (MI); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline is seeking a quality-focused professional to set basic quality standards for in-process and testing methods. You will lead testing and design experiments using SPC to identify improvements and trends.

You will coordinate with suppliers on CAPA, SCAR, and supplier quality programs, and build and maintain regulatory documentation including DMRs and CE files. A Bachelor's in an engineering/science field and 2+ years' experience are typical requirements.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related field.
• 2+ years in Quality or Engineering.

Responsibilities

• Set basic quality standards for in-process and test methods.
• Design experiments using SPC to analyze data and drive improvements.
• Lead testing/examination to limit defects and analyze trends.
• Collaborate with suppliers on CAPA/SCAR and supplier quality.
• Prepare and maintain device master records and CE technical files.

Skills

Quality Assurance

Process control

SPC

CAPA

MS Office

Excel

Problem solving

Time management

Self‑direction

Education

Bachelor's degree in Engineering/Science/Math

Tools

MS Office

Excel

Job description

Medline is seeking a quality-focused professional to set basic quality standards for in-process and testing methods. You will lead testing and design experiments using SPC to identify improvements and trends.

You will coordinate with suppliers on CAPA, SCAR, and supplier quality programs, and build and maintain regulatory documentation including DMRs and CE files. A Bachelor's in an engineering/science field and 2+ years' experience are typical requirements.