What are the responsibilities and job description for the Senior Quality Engineer position at KKR Consulting?
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.
