Reliability Engineer - 260028

Overview

The Reliability Engineer serves as the primary authority and official Management Representative for the Elmhurst (IL) or Kenosha (WI) manufacturing facilities. This role is responsible for establishing, maintaining, and continually improving the Quality Management System (QMS) in strict alignment with FDA 21 CFR Part 820, ISO 13485:2016, and cGMP standards.

The ideal candidate acts as the official liaison to the FDA and notified bodies, understands the medical device industry, manages internal/external audit programs, leads master validation planning, and collaborates across functional teams and suppliers to uphold product quality, regulatory compliance, and patient safety.

Quick Briefing of Duties

• Regulatory Compliance & Management Representation
• Quality Systems & Continuous Improvement
• Validation & Manufacturing Quality Support
• Audits & Supplier Quality

Qualifications

• Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Quality Engineering, or a related technical discipline strongly preferred; or an equivalent combination of education and direct industry experience.
• Experience: 3–5 years of progressive quality engineering and regulatory compliance experience within the medical device manufacturing industry .
• Direct experience serving as a Quality Management Representative or leading FDA/ISO audit readiness is preferred.