Quality Engineer II, Medical Devices - Quality & DV&V

Regulatory Jobs; Santa Clara (CA); Sur place; USD 105 000 - 115 000; Plein temps

Résumé du poste

Shockwave Medical Inc. in Santa Clara, CA is seeking a Quality Engineer II to develop and maintain quality standards for processing materials and products.

You will design inspection methods, support manufacturing, and participate in risk management and process improvements. The role requires a Bachelor's degree in Bioengineering or Biomedical Engineering and 2 years in quality engineering within the medical device industry, with strong technical writing and knowledge of IQ/OQ/PQ and ISO/FDA

Qualifications

• Bachelor's degree in Bioengineering or Biomedical Engineering or related field.
• 2 years of experience in Quality Engineering or related role.
• Experience in medical device industry.
• Experience with non-conformance investigations and product disposition.
• Experience with IQ, OQ, PQ and validation protocols.
• Strong technical writing for investigations, design verifications/validations, and reports.
• Familiarity with ISO, ASTM, and FDA standards for medical devices.

Responsabilités

• Develop, apply, revise and maintain quality standards for processing materials/products.
• Design and implement inspection, testing, and evaluation methods.
• Support manufacturing and cross-functional teams to resolve technical problems.
• Prepare documentation for inspection plans, studies, and defect investigations.
• Assess conformity of components and products and manage non-conformances with a multidisciplinary team.

Connaissances

Quality engineering

Statistical analysis

Technical writing

Risk management

DOE

IQ/OQ/PQ

ISO/FDA standards

Minitab

Formation

Bachelor's degree in Bioengineering or Biomedical Engineering

Outils

Minitab

Description du poste

Shockwave Medical Inc. in Santa Clara, CA is seeking a Quality Engineer II to develop and maintain quality standards for processing materials and products.

You will design inspection methods, support manufacturing, and participate in risk management and process improvements. The role requires a Bachelor's degree in Bioengineering or Biomedical Engineering and 2 years in quality engineering within the medical device industry, with strong technical writing and knowledge of IQ/OQ/PQ and ISO/FDA