Overview
Senior Quality Engineer Jobs in Grand Rapids, MI at KKR Consulting
Title: Senior Quality Engineer
Company: KKR Consulting
Location: Grand Rapids, MI
Key Responsibilities:
Lead and support EU MDR implementation projects and remediation activities.
Review, redline, and approve technical documentation and change orders for MDR compliance.
Coordinate and execute the label verification process with local Quality Engineers.
Assist in the development and execution of FAI, inspection protocols, and product testing.
Ensure project deliverables are completed on time and in compliance with EU MDR standards.
Participate in IQ, OQ, and PQ validation activities as required.
Collaborate with cross-functional teams including Engineering, Manufacturing, and Regulatory Affairs.
Support design and implementation of inspection and testing methods for MDR-compliant product lines.
Review and update process and quality documentation, ensuring alignment with MDR standards.
Provide statistical analysis and recommend corrective actions for non-compliant materials or processes.
Top Skills & Qualifications:
Required:
2–4 years of direct EU MDR compliance/remediation experience.
Strong Quality Engineering experience within a regulated medical device environment.
Ability to thrive in a fast-paced, dynamic project-based environment.
Proficiency with label verification processes and related documentation.
Preferred:
Prior experience with Capital Projects and validation activities (IQ/OQ/PQ).
Familiarity with new product inspection methods and EU MDR-compliant product launches.
Strong background in design control, risk management, and technical documentation for medical devices.
