Senior Design Quality Engineer NPI & Regulatory Compliance

Katalyst CRO; Waukesha (WI); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Quality Engineer specialized in design control to lead design history file reviews, risk management, and regulatory compliance for medical device development. You will guide engineering teams, review DHF/DMR deliverables, and ensure quality by design across NPI projects.

The role requires deep knowledge of FDA/ISO requirements, strong multitasking, and the ability to mentor junior staff while coordinating cross-functional activities across multiple

Qualifications

• Bachelor's degree is required; advanced degree preferred.
• 8–12+ years of experience, or 6+ years with master's.
• Familiar with DHF, DMR, risk management, design verification and validation.
• Ability to multi-task in a fast-paced environment.
• Strong organizational and presentation skills.
• Excellent written and verbal communication.

Responsibilities

• Resolve issues in creative ways within the design control process.
• Ensure projects meet customer expectations and regulatory requirements.
• Act as a subject matter expert on design control and Quality Engineering.
• Address complex engineering issues with in-depth evaluation of variable factors.
• Provide guidance to engineering staff and ensure design control requirements are met.
• Input to DHF deliverables including material specs, drawings, inspection procedures, and manufacturing procedures.
• Review and approve design control related Change Notices (CNs).
• Coordinate Design Assurance activities of other team members.
• Create processes and improvements to ensure internal and external regulatory compliance.
• Represent design quality functions for review and approval of design outputs.
• Assist in development and maintenance of procedures for design control, change management, risk management and PV.
• Represent QA to FDA, ISO and auditors.
• Work independently on high visibility NPD projects across technologies and sites.
• Maintain knowledge of regulatory requirements and standards for development and release of medical devices.
• Provide mentorship to junior staff and escalate issues as needed.
• Assist with various projects as assigned by supervisor.
• Other duties as assigned.

Skills

Design control process

Quality Engineering

Regulatory compliance

Mentorship

Leadership

Education

Bachelor's Degree

Advanced Degree

Job description

Katalyst CRO is seeking an experienced Quality Engineer specialized in design control to lead design history file reviews, risk management, and regulatory compliance for medical device development. You will guide engineering teams, review DHF/DMR deliverables, and ensure quality by design across NPI projects.

The role requires deep knowledge of FDA/ISO requirements, strong multitasking, and the ability to mentor junior staff while coordinating cross-functional activities across multiple