Principal/Staff Quality Engineer

Staff/Principal Quality Engineer

An innovative medical device company developing next-generation surgical technology is seeking a Staff / Principal Quality Enginee r to play a key role in ensuring quality is built into products from concept through commercialization

Working closely with Engineering, Manufacturing, and Regulatory teams, this individual will support product development, supplier quality, manufacturing transfers, risk management, and regulatory compliance for Class II medical device.

Key Responsibilities

• Ensure quality is integrated throughout product design, development, and manufacturing.
• Support product qualifications, including electrical safety, biocompatibility, and sterilization validation.
• Lead risk management activities, including DFMEA, PFMEA, and quality planning.
• Develop inspection methods, quality control plans, and receiving inspection requirements.
• Support engineering builds, process validation, and manufacturing transfers.
• Partner with suppliers to resolve quality issues, perform supplier qualifications, and support supplier audits.
• Lead CAPA, NCR, root cause investigations, and continuous improvement initiatives.

Qualifications

• 5+ years of Quality Engineering experience within the medical device industry.
• Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
• Experience supporting design controls, product development, manufacturing, and supplier quality.
• Familiarity with IEC 60601, IEC 62304, ISO 10993, and ISO 11135 is a plus.
• Experience with electronic assemblies (PCB/PCBA), GD&T, statistical analysis, and process validation preferred.