Quality Systems & Regulatory Engineer (FDA/ISO)

ARCH; Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Job summary

ARCH is seeking a Quality System Management Representative responsible for the Elmhurst, IL and Kenosha, WI facilities. You will promote regulatory and QMS awareness, train staff, and maintain essential quality processes in line with ISO 13485 and FDA 21 CFR 820.

You will lead audits, support CAPA and MRB activities, and coordinate with vendors and internal teams to ensure product quality and regulatory compliance across sites.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering (or equivalent).
• 5–10 years in medical device manufacturing Quality Engineering or related roles.
• Knowledge of ISO 13485 and FDA 21 CFR 820 Regulations.
• Knowledge of Geometric Dimensioning and Tolerancing (ASME Y14.5M).
• Familiarity with test methods and design verification/validation.

Responsibilities

• Acts as Quality System Management Representative for Elmhurst, IL and Kenosha, WI facilities.
• Promotes awareness of regulatory and QMS requirements; trains personnel.
• Establishes, implements, and maintains QMS processes.
• Leads internal/external audits and interfaces with FDA oversight.
• Coordinates quality improvements, CAPA, and supplier quality activities.

Skills

Quality Systems

Regulatory Knowledge

Audits

GMP/GxP

Education

Bachelor's in Mechanical or Biomedical Eng

Job description

ARCH is seeking a Quality System Management Representative responsible for the Elmhurst, IL and Kenosha, WI facilities. You will promote regulatory and QMS awareness, train staff, and maintain essential quality processes in line with ISO 13485 and FDA 21 CFR 820.

You will lead audits, support CAPA and MRB activities, and coordinate with vendors and internal teams to ensure product quality and regulatory compliance across sites.