Regulatory Compliance Engineer

Location: Kalamazoo, MI, United States

Company

hirify.global Manufacturing and hirify.global Tekna provide engineering, design consulting, contract manufacturing, and original equipment manufacturing services across medical, industrial, aerospace, healthcare, biotech, and other product sectors.

What you will do

• Execute Regulatory Compliance tasks within the Quality Management System for New Product Development projects.
• Support project leadership and project management with Design History Files, project plans, product requirements, and quality-system compliance.
• Lead risk management activities, coordinate Risk Management Board reviews, and complete launch-related risk reports.
• Support manufacturing, procurement, and design teams with 6M analysis, PPAP, FMECA, process-flow documentation, and Design for Manufacturing Analysis.
• Design and develop verification procedures for incoming, in-process, and final inspections.
• Support process validation and qualification, third-party certification testing, and design transfer from New Product Development to Operations.

Requirements

• Bachelor of Science degree in engineering preferred.
• 1–3 years of experience in Regulatory Compliance or Advanced Quality, or 5+ years of New Product Development experience preferred.
• Proficiency in statistical analysis and process control preferred.
• Ability to read blueprints and use computers proficiently.
• Strong problem-solving, communication, and organizational skills.

Culture & Benefits

• Fast-paced environment with diverse engineering and manufacturing projects.
• Opportunities to take on responsibility, receive experienced-based coaching, and work with cross-functional teams.
• Professional growth opportunities through association with hirify.global Manufacturing.
• Equal Employment Opportunity and Affirmative Action employer.
• Reasonable accommodations are available for qualified individuals with disabilities during the application process.