NPD Quality Engineer

We are seeking a Quality Engineer to support New Product Development (NPD) initiatives. The NPD Quality Engineer is responsible for ensuring new products meet customer, regulatory, and internal quality standards
throughout the design and development process. This role involves collaborating with cross-functional teams, implementing quality control plans, and driving continuous improvement in product design and manufacturing.

NPD Support: Work closely with Supplier Quality, R&D, Design, Manufacturing, and Supply
Chain teams to integrate quality into product designs. Ensure compliance with established
KPIs. Participate in design reviews, validation, and verification activities to ensure products
meet quality and regulatory requirements. Conduct risk assessments (DFMEA, PFMEA, and process capability studies) to identify and mitigate potential quality issues
Quality Planning & Compliance: Develop and implement Quality Control Plans (QCPs), inspection criteria, and test methods for new products. Ensure compliance with relevant standards and regulations (e.g., ISO 9001, ISO 13485, AS9100, IATF 16949, FDA regulations, etc.). Drive supplier quality management to ensure components and materials meet
specifications. Testing & Validation: Support Design Validation (DV), Process Validation (PV), and Qualification (IQ/OQ/PQ) activities. Develop and execute measurement system analysis (MSA), Gauge R&R, and statistical analysis
Continuous Improvement & Problem-Solving: Use Six Sigma, Lean, and Root Cause Analysis (RCA) tools to investigate and resolve quality issues. Lead corrective and preventive actions (CAPA), 8D reports, and non-conformance resolution. Identify opportunities for process
improvements and efficiency in product development.
Documentation & Reporting: Maintain accurate quality records, test reports, and
documentation in accordance with industry standards. Prepare and present quality reports, dashboards, and key performance indicators (KPIs) to management.