Manufacturing Quality Engineer

KKR Consulting • Contract • New Hampshire, United States, US • 4d ago

KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.

Title: NPI Quality Engineer

Location: New Hampshire (On-site)

Role Overview:

We are seeking a Quality Engineer to support the development and continuous improvement of medical device products in the New Product Introduction (NPI) phase. The ideal candidate will collaborate with R&D, Manufacturing, Regulatory, and Supplier Quality teams to ensure compliance with ISO 13485, FDA 21 CFR 820, and other relevant standards.

Key Responsibilities:

Participate in NPD and NPI projects to ensure quality and regulatory requirements are integrated into product design and development.
Lead quality deliverables for NPI, including risk management, PFMEA/DFMEA, and validation planning.
Support design transfer to manufacturing, ensuring process capability and compliance with quality system procedures.
Review CAD models, technical drawings, and specifications for manufacturability and compliance with design controls.
Facilitate design reviews and resolve discrepancies between engineering drawings and product requirements.
Develop and execute test methods, V&V protocols, and reports to ensure product quality.
Support risk management and corrective action processes, including CAPA and root-cause analysis.
Ensure documentation is in compliance with ISO 13485, FDA QSR, and other applicable standards.

Required Skills and Qualifications:

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.
4–6+ years of experience in Quality Engineering within the medical device industry.
Experience with ISO 13485, FDA 21 CFR 820, and other relevant regulatory standards.
Proficiency with CAD systems (SolidWorks, Creo, NX, or similar).
Strong analytical skills in root-cause analysis, statistical methods, and problem-solving tools.
Experience in NPI/NPD projects and working with cross-functional teams.
Excellent communication, documentation, and problem-solving skills.

Benefits: