Quality Engineer - Medical Devices & Process Improvement

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality/Engineering professional to independently set basic quality standards and lead testing, sampling, and training efforts. You will evaluate production processes, recommend improvements, and manage DMRs, product specs, design control files, and CE technical files.

The role involves designing experiments, conducting product testing, and collaborating with suppliers to drive CAPA and supplier quality programs.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Travel up to 15%.
• Experience with SPC and CAPA processes.
• Familiarity with 21 CFR 820 and ISO 13485.

Responsibilities

• Manage development and implementation of methods for process control, validation, improvement, testing and inspection.
• Design experiments to understand variation and apply SPC for data analysis.
• Lead supplier qualifications and collaborate on CAPA/SCAR actions.
• Provide quality expertise in Product Development, Design Control, Risk Management and CE files.
• Lead investigations of non-conformances and drive CAPA actions.

Education

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

Tools

MS Office

Excel

Job description

Medline Industries, LP is seeking a Quality/Engineering professional to independently set basic quality standards and lead testing, sampling, and training efforts. You will evaluate production processes, recommend improvements, and manage DMRs, product specs, design control files, and CE technical files.

The role involves designing experiments, conducting product testing, and collaborating with suppliers to drive CAPA and supplier quality programs.