Manufacturing Quality Engineer
Job in
Portsmouth, Rockingham County, New Hampshire, 00215, USA
Listed on 2026-02-12
Listing for:
KKR Consulting
Full Time
position Listed on 2026-02-12
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Biomedical Engineer, Process Engineer
Job Description & How to Apply Below
KKR Consulting partners with businesses to solve challenges and streamline processes. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries.
Title: NPI Quality Engineer
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.
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 (Solid Works, 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.
- Medical insurance
- Vision insurance
- 401(k)
Mid-Senior level
Employment TypeContract
Job FunctionMedical Equipment Manufacturing
#J-18808-LjbffrTo View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×