Onsite Manufacturing Quality Engineer - Howell, MI

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

Job summary

Medline Industries, LP in Howell, MI is seeking a Manufacturing Quality Engineer to independently set basic quality standards and lead testing, sampling, and training efforts. You will evaluate production processes, conduct testing, and manage DMRs and CE files to ensure regulatory compliance.

The role involves SPC-based data analysis, vendor collaboration, CAPA and supplier qualification leadership, plus documentation of design controls and risk management. Travel is up to 15% as needed.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 2 years of experience in Quality or Engineering.
• Experience with SPC, CAPA/SCAR, and supplier management.

Responsibilities

• Develop and implement methods for process control and validation.
• Design experiments to identify sources of variation.
• Lead supplier quality improvements and CAPA programs.
• Prepare and maintain DMRs, design control files, and CE files.
• Coordinate product testing with labs and regulatory groups.
• Ensure compliance with 21 CFR 820 and ISO 13485.

Skills

Time management

Problem solving

MS Office

Attention to detail

Teamwork

Education

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

Tools

Microsoft Excel

PowerPoint

Outlook

Job description

Medline Industries, LP in Howell, MI is seeking a Manufacturing Quality Engineer to independently set basic quality standards and lead testing, sampling, and training efforts. You will evaluate production processes, conduct testing, and manage DMRs and CE files to ensure regulatory compliance.

The role involves SPC-based data analysis, vendor collaboration, CAPA and supplier qualification leadership, plus documentation of design controls and risk management. Travel is up to 15% as needed.