Senior Quality Engineer - Medical Devices (Hybrid/Remote)

Stryker Corporation; Fremont (CA); Hybride; USD 101 000 - 168 000; Plein temps

Résumé du poste

Stryker Corporation in Fremont, CA is hiring a Senior Quality Engineer to support the Neurovascular division in a hybrid/onsite capacity. You will lead product risk management, post-market surveillance, design controls, and quality improvement across the lifecycle of NV products.

You will develop qualification plans, perform tests and validation, conduct root cause analyses, and maintain risk documentation while collaborating with engineering, regulatory, and manufacturing teams to ensure

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Minimum 2 years in engineering, quality engineering, manufacturing engineering, or a related technical role.
• Experience using structured problem-solving methodologies and quality improvement tools.
• Knowledge of design controls, risk management, and quality system requirements.
• Experience with statistical analysis, test method development, and validation activities.

Responsabilités

• Develop qualification plans, protocols, and reports for new products, existing products, components, and subassemblies.
• Execute product testing, inspection, verification, and validation activities to support design and quality objectives.
• Perform failure investigations and root cause analyses to identify product and process improvement opportunities.
• Create, maintain, and update product risk management documentation throughout the product lifecycle.
• Collaborate with engineering, regulatory, manufacturing, and quality teams to support product development, design changes, and compliance activities.

Connaissances

Root cause analysis

Statistical analysis

Risk management

Quality engineering

Problem solving

Formation

Bachelor's degree in Engineering

Description du poste

Stryker Corporation in Fremont, CA is hiring a Senior Quality Engineer to support the Neurovascular division in a hybrid/onsite capacity. You will lead product risk management, post-market surveillance, design controls, and quality improvement across the lifecycle of NV products.

You will develop qualification plans, perform tests and validation, conduct root cause analyses, and maintain risk documentation while collaborating with engineering, regulatory, and manufacturing teams to ensure