Regulatory Compliance Engineer — NPD & Quality Lead

Re:Build Manufacturing; Kalamazoo, Northern (MI, KY); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Re:Build Manufacturing is seeking a Regulatory Compliance Engineer to execute tasks under Tekna’s Quality Management System, ensuring product safety, reliability, and regulatory compliance for New Product Development.

You will support NPD projects, lead risk management activities, and collaborate with design, production, procurement, and QA teams to achieve successful product launches while adhering to export control requirements.

Qualifications

• Bachelor of science degree in engineering preferred.
• 1 to 3 years’ experience in Regulatory Compliance or Advanced Quality and/or 5+ years in new product development preferred.
• Proficiency in statistical analysis and control preferred.
• Organizational skills.

Responsibilities

• Support Core Leadership on NPD projects and mentor other compliance engineers.
• Assist in creating a Design History File and ensure conformance with the Quality Management System.
• Initiate and maintain project plans to optimize quality, schedule, and cost.
• Lead risk management and coordinate risk review for product launch.
• Support production, procurement, and design teams with PPAP and FMECA.

Skills

Regulatory compliance

Statistical analysis

Organizational skills

Education

Bachelor of science in engineering

Job description

Re:Build Manufacturing is seeking a Regulatory Compliance Engineer to execute tasks under Tekna’s Quality Management System, ensuring product safety, reliability, and regulatory compliance for New Product Development.

You will support NPD projects, lead risk management activities, and collaborate with design, production, procurement, and QA teams to achieve successful product launches while adhering to export control requirements.