Manufacturing Quality Engineer – Medical Devices & Compliance

Medline Industries, LP; 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 Industries, LP in Howell, MI is seeking a Quality Engineer with responsibility to set basic quality standards for in-process work and to lead methods for testing, sampling and training. You will evaluate production processes, qualify vendors, generate and maintain DMRs, product specifications, design control files and CE technical files.

The role emphasizes SPC, design of experiments, CAPA/SCAR, supplier qualifications, and collaboration with Regulatory groups to produce 510(k)

Qualifications

• Bachelor’s degree in a technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience with MS Office Suite and Excel.
• Knowledge of quality assurance codes and standards (e.g., 21 CFR 820, ISO13485).

Responsibilities

• Set basic in-process quality standards and lead methods for testing, sampling and training.
• Evaluate production processes and recommend improvements.
• Lead supplier qualifications and CAPA/SCAR activities.
• Coordinate 510K submissions and regulatory documentation.
• Perform quality reviews of design documentation and vendor quality records.

Skills

MS Office

Excel

Time management

Problem solving

Quality standards (21 CFR 820, ISO1345

Education

Bachelor’s degree in Engineering/Science/Math

Job description

Medline Industries, LP in Howell, MI is seeking a Quality Engineer with responsibility to set basic quality standards for in-process work and to lead methods for testing, sampling and training. You will evaluate production processes, qualify vendors, generate and maintain DMRs, product specifications, design control files and CE technical files.

The role emphasizes SPC, design of experiments, CAPA/SCAR, supplier qualifications, and collaboration with Regulatory groups to produce 510(k)