Senior Quality Engineer, Advanced Wound Care

Medline Industries, LP; United States; On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a quality engineer to independently set basic quality standards, lead process testing, sampling, and training efforts. You will evaluate production processes, propose improvements, qualify vendors, generate DMRs and design control files, and support regulatory submissions such as 510K.

The role requires at least 4 years in Quality or Engineering with knowledge of FDA/ISO standards.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering with knowledge of government and industry QA codes and standards.
• Experience using MS Office Suite (Word, Excel, PowerPoint, Outlook) and data analysis.

Responsibilities

• Develop and implement methods and procedures for process control, validation, testing, and inspection to ensure product quality.
• Design experiments to understand sources of variation and determine root causes.
• Apply SPC methods to analyze data and guide process improvements.
• Lead supplier qualifications and coordinate CAPA/SCAR activities with suppliers.
• Prepare and maintain documentation (DMRs, product specs, design control, CE files) and support 510K submissions.

Job description

Medline Industries, LP is seeking a quality engineer to independently set basic quality standards, lead process testing, sampling, and training efforts. You will evaluate production processes, propose improvements, qualify vendors, generate DMRs and design control files, and support regulatory submissions such as 510K.

The role requires at least 4 years in Quality or Engineering with knowledge of FDA/ISO standards.