Senior Quality Engineer, Medical Devices & CE Compliance

Regulatory Jobs; Northfield Township (IL); On-site; USD 101,000 - 152,000; Full time

Job summary

Regulatory Jobs seeks a Quality/Engineering professional to independently set basic quality standards for in-process activities and lead efforts to develop testing, sampling, and training methods. You will evaluate production processes, drive improvements, qualify suppliers, and maintain DMRs, product specs, and CE tech files.

Responsibilities include CAPA, supplier qualifications, and 510K coordination. The role requires a Bachelor’s degree in a technical field and 4+ years in quality or

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience applying government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards).

Responsibilities

• Manage development and implementation of methods and procedures for process control, validation, testing, and inspection.
• Design experiments to understand variation sources and apply SPC to evaluate processes.
• Design and perform tests to maintain quality and minimize defects; generate reports; apply probability concepts.
• Collaborate with suppliers on quality issues; implement CAPA; lead supplier qualifications.
• Provide quality expertise in development, design controls, risk management, and CE files; coordinate 510K submissions.
• Ensure compliance with domestic and international regulations; review design documentation and vendor quality records.
• Lead investigations of non-conformances and CAPA actions.
• Train and coach team members and Medline staff on processes.
• Serve as quality lead in the absence of the Quality Management function.

Skills

Quality Engineering

CAPA

Supplier Quality

SPC

MS Excel

Travel up to 15%

Education

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

Job description

Regulatory Jobs seeks a Quality/Engineering professional to independently set basic quality standards for in-process activities and lead efforts to develop testing, sampling, and training methods. You will evaluate production processes, drive improvements, qualify suppliers, and maintain DMRs, product specs, and CE tech files.

Responsibilities include CAPA, supplier qualifications, and 510K coordination. The role requires a Bachelor’s degree in a technical field and 4+ years in quality or