Biomedical Engineer

Role And Responsibilities:

• Actively partner with Manufacturing departments, providing tactical Quality support to the teams
• Lead root cause analysis, implement/provide corrective actions and ensure their effectiveness
• Create, maintain and evaluate product/process trends, designing and participating in process and product improvement plans
• Ensure risk assessment activities are completed for relevant processes/products (i.e. dFMEA, pFMEA)
• Participate in Product Development Process assuring design quality elements are maintained and compliant with ISO 13485 and applicable regulations

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

• 2+ year experience in a Quality Engineering position – familiarity with and execution of principles within Certified Quality Engineer (ASQ CQE) Body of Knowledge
• BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or demonstrated equivalent work experience in the Quality Engineering area pertaining to a scientific industry
• Knowledge in standards such as ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, ISO 9001:2015 – Quality Management Systems, and ISO 14971 Medical Devices – Risk Management.

Job Type: Contract

Salary: $30.00 - $37.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Medial Devices: 3 years (Required)

Ability to Commute:

• Fremont, CA 94538 (Required)

Work Location: In person