Senior Operations Quality Engineer - Medical Device Equity

Regulatory Jobs; Burlingame (CA); Sur place; USD 150 000 - 190 000; Plein temps

Résumé du poste

Neptune Medical, a Burlingame, CA–based medical device startup, seeks a Sr. Operations Quality Engineer to support volume production, new product introductions, and continuous improvement of assembly processes.

You will work with production, quality control, and cross-functional teams to improve efficiency, reduce costs, and ensure product quality across the facility. The role emphasizes leadership, ownership, and hands-on problem solving in a fast-paced startup environment.

Qualifications

• Bachelor’s degree in an engineering field; Master’s preferred.
• 5–7 years of professional engineering in medical devices.
• 3+ years in manufacturing or operations preferred.
• Proficiency with GMP/ISO13485 and related standards.
• Strong leadership, mentoring, and communication skills.
• Experience with EDMS, ERP, and manufacturing software.

Responsabilités

• Identify opportunities for quality improvements, cost reduction, and production scaling.
• Author and maintain inspection documentation, QIPs, WIs, TMs, and drawings.
• Review manufacturing protocols and related documentation.
• Support validation activities (IQ/OQ/PQ) and generate detailed reports.
• Provide technical quality support to production floors and QC areas.
• Lead NCR and CAPA initiatives; participate in supplier qualification and process transfers.

Formation

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Mechanical Engineering

Master's degree preferred

Outils

Minitab

JMP

EDMS

ERP systems

Manufacturing software

Description du poste

Neptune Medical, a Burlingame, CA–based medical device startup, seeks a Sr. Operations Quality Engineer to support volume production, new product introductions, and continuous improvement of assembly processes.

You will work with production, quality control, and cross-functional teams to improve efficiency, reduce costs, and ensure product quality across the facility. The role emphasizes leadership, ownership, and hands-on problem solving in a fast-paced startup environment.