Regulatory Quality Engineer — Medical Devices (FDA/ISO)

Arch-Medical-Solutions; Kenosha (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Arch-Medical-Solutions is seeking a Quality System Management Representative to oversee the quality system at Elmhurst, IL and Kenosha, WI facilities. You will promote regulatory awareness, train staff on QMS standards, and drive compliance with FDA QSR, ISO 13485, and related regulations.

The role includes leading CAPA and MRB activities, coordinating audits, and managing process validation with internal and external stakeholders.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering or equivalent.
• 5–10 years of experience in medical device manufacturing quality engineering.
• Knowledge of ISO 13485 Quality Management System and FDA 21 CFR 820 Regulations.
• Familiarity with Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5M.
• Experience with design verification and validation and regulatory training.

Responsibilities

• Act as Quality System Management Representative for Elmhurst (IL) and Kenosha (WI) facilities.
• Promote awareness of regulatory and quality management system requirements; assist training on QMS and regulatory standards.
• Establish, implement, and maintain processes for the quality management system.
• Ensure compliance with FDA QSR, GMP, GDP, ISO 13485 and other applicable regulations.
• Lead or participate in development, implementation, and maintenance of standards and procedures (FDA, ISO 13485:2016, etc.).
• Act as a direct contact for FDA; ensure FDA registrations and device listings are current.
• Support ECO, CAPA, MRB and other QMS processes; create metrics to monitor process performance.
• Coordinate manufacturing process validation and maintain master validation program with stakeholders.
• Organize investigations and drive root-cause determinations and corrective action effectiveness.

Skills

Regulatory knowledge

QA Audits

Training

GMP basics

ISO 13485

Education

Bachelor's degree in mechanical or biomedical engineering

5–10 years medical device quality experience

Job description

Arch-Medical-Solutions is seeking a Quality System Management Representative to oversee the quality system at Elmhurst, IL and Kenosha, WI facilities. You will promote regulatory awareness, train staff on QMS standards, and drive compliance with FDA QSR, ISO 13485, and related regulations.

The role includes leading CAPA and MRB activities, coordinating audits, and managing process validation with internal and external stakeholders.