Medical Device Quality Engineer: SPC, CAPA & Design Control

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

Job summary

Medline Industries, LP is seeking a qualified Quality Assurance professional to independently set basic quality standards for in‑process and lead method development for testing, sampling and training. Responsibilities include evaluating production processes, vendor management, and maintaining DMRs, product specs, and CE technical files.

Key duties involve designing experiments, applying SPC, leading CAPA/SCAR actions, and ensuring compliance with 21 CFR 820 and ISO13485.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience applying quality codes and standards (e.g. 21 CFR 820, ISO13485).
• Experience problem solving and CAPA/SCAR activities.

Responsibilities

• Establish methods for process control, validation, improvement, testing and inspection.
• Apply SPC to analyze data and guide process changes.
• Lead supplier qualifications and corrective action programs.
• Develop and maintain product documentation in compliance with regulations.
• Coordinate testing with internal and external labs for filings.
• Lead investigations of non-conformances and CAPA.

Skills

Quality Assurance

SPC

CAPA

Vendor management

Design Control

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Science

Tools

MS Office Suite

Microsoft Excel

Job description

Medline Industries, LP is seeking a qualified Quality Assurance professional to independently set basic quality standards for in‑process and lead method development for testing, sampling and training. Responsibilities include evaluating production processes, vendor management, and maintaining DMRs, product specs, and CE technical files.

Key duties involve designing experiments, applying SPC, leading CAPA/SCAR actions, and ensuring compliance with 21 CFR 820 and ISO13485.