Regulatory Quality Engineer (Medical Devices)

ARCH; Kenosha (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

ARCH is seeking a Quality System Management Representative to oversee the Elmhurst, IL and Kenosha, WI facilities. You will promote awareness of applicable regulatory and QMS requirements, train personnel, and ensure QMS processes are established, implemented, and maintained.

The role requires strong knowledge of FDA 21 CFR 820, ISO 13485, and related standards, with responsibility for internal/external audits, CAPA, and supplier coordination across sites.

Qualifications

• Bachelor's degree in engineering or equivalent required.
• 5–10 years in medical device manufacturing quality engineering.
• Knowledge of ISO 13485 and FDA 21 CFR 820.
• Familiarity with GD&T (ASME Y14.5M).
• Experience with GMP, GDP, ISO 13485:2016 and related standards.

Responsibilities

• Act as Quality System Management Representative for Elmhurst and Kenosha facilities.
• Promote awareness of regulatory and QMS requirements across the organization.
• Lead or participate in establishing, implementing, and maintaining QMS processes.
• Coordinate FDA registrations and device listings; maintain compliance.
• Lead audits and supplier/process audits; document findings and actions.
• Develop and monitor CAPA, ECO, MRB and other QMS processes.
• Design and deliver ISO internal training and validation programs.
• Organize investigations and drive root cause analysis and corrective actions.

Skills

Quality management

Regulatory knowledge

Training personnel

Internal/External audits

Root cause analysis

Education

Bachelor's degree in mechanical or bio-medical engineering

Tools

Geometric Dimensioning and Tolerancing (ASME Y14.5M)

Job description

ARCH is seeking a Quality System Management Representative to oversee the Elmhurst, IL and Kenosha, WI facilities. You will promote awareness of applicable regulatory and QMS requirements, train personnel, and ensure QMS processes are established, implemented, and maintained.

The role requires strong knowledge of FDA 21 CFR 820, ISO 13485, and related standards, with responsibility for internal/external audits, CAPA, and supplier coordination across sites.