Senior Quality Engineer — Medical Devices & Validation

MiniMed; Los Angeles (CA); Sur place; USD 97 000 - 165 000; Plein temps

Avantages offerts par ce poste

Health Insurance

401(k) with company match

Employee Stock Purchase Plan

Short-term Incentive

Résumé du poste

MiniMed seeks a Senior Quality Engineer to lead quality across manufacturing operations, driving validation, CAPA, and continuous improvement in a highly regulated environment. You will design inspection methods, perform statistical analysis, and ensure products meet FDA/ISO 13485 standards and 21 CFR Part 820 requirements.

You will partner with Engineering and Manufacturing to establish robust controls and validated lines for new product launches, ensuring compliance and patient safety in every

Qualifications

• Must have a technical engineering/science degree with several years of quality or engineering work experience.
• Excellent understanding of FDA, ISO 13485, and 21 CFR Part 820 regulatory requirements.

Responsabilités

• Develops, applies and maintains quality standards and protocols across the production lifecycle.
• Collaborates with engineering and manufacturing to ensure continuous quality improvements.
• Plans, inspects, tests, and evaluates product and equipment quality and documentation.

Formation

Bachelor’s Degree in Engineering, Science or technical field

Advanced Degree in Engineering, Science or technical field

Description du poste

MiniMed seeks a Senior Quality Engineer to lead quality across manufacturing operations, driving validation, CAPA, and continuous improvement in a highly regulated environment. You will design inspection methods, perform statistical analysis, and ensure products meet FDA/ISO 13485 standards and 21 CFR Part 820 requirements.

You will partner with Engineering and Manufacturing to establish robust controls and validated lines for new product launches, ensuring compliance and patient safety in every