Regulatory Compliance Engineer: Lead NPD Quality & Safety

Re:Build Manufacturing; Kalamazoo (MI); On-site; USD 70,000 - 100,000; Full time

Job summary

Re:Build Manufacturing is seeking a Regulatory Compliance Engineer to join our Tekna division in Kalamazoo, MI. You’ll execute tasks under our Quality Management System to ensure product safety, efficacy, reliability, and regulatory compliance across New Product Development.

You’ll lead risk management activities, support design transfer, and work with cross-functional teams on PPAP, FMECA, and validation to meet regulatory standards and project goals in a fast-paced environment.

Qualifications

• BS in engineering preferred.
• 1–3 years in Regulatory Compliance or 5+ years in NPD preferred.
• Proficiency in statistics and control preferred.
• Read blueprints.
• Computer literacy.
• Problem-solving, communication and organizational skills.

Responsibilities

• Support Core Leadership on NPD projects and mentor compliance engineers.
• Assist Project Manager with Design History File and QMS conformance.
• Create and maintain plans to optimize product quality, schedule and cost.
• Research and establish product requirements.
• Lead risk management and coordinate Risk Management Board reviews.
• Support Production Engineer with 6M analysis for production processes.
• Support Procurement with supply chain management and PPAP.
• Assist Design and Production with FMECA.
• Overwatch safety compliance and basic regulatory standards.
• Conduct design for manufacturing analyses.
• Assist with process flow/layout diagrams and verification tests.
• Support verification/validation matrices and process qualification (IQ/OQ/PQ).
• Coordinate in-house test methods and third-party certification testing.

Skills

Read blueprints

Statistical analysis

Problem solving

Communication

Organizational skills

Education

BS in engineering

Job description

Re:Build Manufacturing is seeking a Regulatory Compliance Engineer to join our Tekna division in Kalamazoo, MI. You’ll execute tasks under our Quality Management System to ensure product safety, efficacy, reliability, and regulatory compliance across New Product Development.

You’ll lead risk management activities, support design transfer, and work with cross-functional teams on PPAP, FMECA, and validation to meet regulatory standards and project goals in a fast-paced environment.