Regulatory Compliance Engineer

Re:Build Manufacturing • Kalamazoo, MI

2d

About The Position

The Regulatory Compliance Engineer is responsible to execute tasks as directed by Tekna’s Quality Management System in support of New Product Development and to ensure product safety, efficacy, reliability, and compliance to applicable regulatory requirements.

Requirements

• Read blueprints
• Computer literacy
• Problem solving skills
• Communication skills
• Organizational skills

Nice To Haves

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

Responsibilities

• Support the Core Leadership role on NPD projects.
• Delegate and provide mentorship of other compliance engineers assigned to your NPD projects.
• Support the Project Manager in the creation of a Design History File and ensure conformance/compliance with the Quality Management System.
• Initiate and maintain project plans that optimize product quality, project schedule, and project/product cost per the Master Project Plan.
• Conduct necessary research and establish product requirements.
• Lead risk management and coordinate the Risk Management Board review.
• 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 developing the production process.
• Support the Procurement Specialist with supply chain management and PPAP.
• Support the Design Engineer and Production Engineer with Failure Mode and Effects Analysis (FMECA).
• Overwatch design for basic safety requirements ensuring 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/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) achieving Cpk/Ppk objectives.
• Support the Design Engineer in setting up and qualifying in-house verification test methods and coordinating 3rd party certification testing in compliance with applicable standards/regulations.
• Support design transfer from NPD DHF to Operations PDM.

What This Job Offers

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