Regulatory Compliance Engineer

Re:Build Manufacturing • Kalamazoo, MI

2d

About The Position

The Regulatory Compliance Engineer completes tasks under Tekna’s quality assurance framework to support new product development (NPD) and ensure product safety, efficacy, reliability, and compliance with applicable regulatory requirements. The role supports NPD project leadership and coordination, quality system conformance, product and process risk management, manufacturing readiness, and design transfer to Operations.

Requirements

• Bachelor of Science degree in engineering preferred.
• 1 to 3 years of experience in Regulatory Compliance or Advanced Quality, and/or 5 or more years of experience in new product development preferred.
• Read blueprints.
• Computer literacy.
• Problem-solving skills.
• Communication skills.
• Organizational skills.

Nice To Haves

• Bachelor of Science degree in engineering.
• 1 to 3 years of experience in Regulatory Compliance or Advanced Quality, and/or 5 or more years of experience in new product development.
• Proficiency in statistical analysis and control.

Responsibilities

• Support the Core Leadership role on NPD projects.
• Delegate work to and mentor other compliance engineers assigned to NPD projects.
• Support the Project Manager in creating a Design History File and ensure conformance with the Quality Management System.
• Initiate and maintain project plans that optimize product quality, project schedule, and project or product cost in accordance with the Master Project Plan.
• Conduct research and establish product requirements.
• Lead risk management and coordinate Risk Management Board reviews.
• Complete the Risk Management report required to achieve product launch.
• Support the Production Engineer, typically an Advanced Manufacturing Engineer (AME), with 6M analysis as part of production process development.
• Support the Procurement Specialist with supply chain management and PPAP.
• Support the Design Engineer and Production Engineer with Failure Mode and Effects Analysis (FMECA).
• Oversee design for basic safety requirements and ensure compliance with applicable safety standards.
• Conduct Design for Manufacturing Analysis.
• Support the Production Engineer in completing Process Flow and Layout Diagrams.
• Design and develop verification processes and procedures for incoming, in-process, and final inspection in support of the established production process.
• Support the Production Engineer in completing the Process Verification and Validation Matrix.
• Support the Production Engineer in completing process qualification (installation qualification, operational qualification, and performance qualification) and achieving Cpk/Ppk objectives.
• Support the Design Engineer in setting up and qualifying in-house verification test methods and coordinating third-party certification testing in compliance with applicable standards and regulations.
• Support design transfer from the NPD Design History File (DHF) to Operations PDM.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level