Principal Design Quality Engineer

Roles & Responsibilities

• Participate in NPI and DHF/DMR reviews meetings.
• Ensure projects comply with internal design control procedures and FDA/ISO requirements.
• Resolve issues creatively and ensure projects meet customer and regulatory expectations.
• Act as a subject matter expert on design control process and Quality Engineering.
• Provide guidance to engineering staff and ensure design control requirements are met.
• Review DHF files for accuracy and completeness and provide guidance on FDA compliance.
• Coordinate Design Assurance activities and assist with complex tasks requiring judgment and initiative.
• Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations.
• Represent design quality functions during FDA, ISO, and auditor reviews.
• Work independently on high visibility new product development projects involving multiple technologies and design sites.
• Maintain knowledge of current regulatory requirements and standards.
• Provide mentorship and assistance to junior level staff and escalate issues as necessary.
• Assist with various projects as assigned.

Requirements

• Bachelor's Degree required; advanced degree preferred.
• 8-12+ years of experience or 6+ years with a master's degree.
• Familiarity with critical elements of the design history file including risk management, design verification, and validation tests.
• Ability to multi-task and operate within a fast-paced environment.
• Strong organizational and presentation skills.
• Excellent oral, written, analytical, and computer skills.