Quality Systems Engineer

Nudge • San Francisco, CA

1d

About The Position

As a Quality Systems Engineer at Nudge, you will:
Ensure that new and existing product designs and processes meet all internal and regulatory requirements with respect to safety and performance
Partner in new product development by leading quality critical discussions, influencing key decisions, and driving necessary process changes across design controls, investigational studies, and clinical trials.
Effectively manage multiple tasks and drive execution of change orders
Initiate and/or support corrective action and preventive action (CAPAs) and non-conformances, leading investigations and implementing mitigations
Represent and cultivate a culture of quality by working with interdisciplinary teams to set expectations, identify gaps, and meet a high internal bar for rigor

Requirements

• Experience with design controls, product/process validation, and risk management
• A degree in an engineering or scientific discipline (e.g., biomedical engineering, electrical engineering, neuroscience) or equivalent hands-on experience
• Familiarity with Good Clinical Practice (GCP) and human factors
• Familiarity with the FDA QMSR, ISO 13485, and ISO 14971
• Experience conducting risk management activities using tools such as failure mode and effects analysis (FMEA)
• Strong technical writing skills
• High integrity

Responsibilities

• Ensure that new and existing product designs and processes meet all internal and regulatory requirements with respect to safety and performance
• Partner in new product development by leading quality critical discussions, influencing key decisions, and driving necessary process changes across design controls, investigational studies, and clinical trials.
• Effectively manage multiple tasks and drive execution of change orders
• Initiate and/or support corrective action and preventive action (CAPAs) and non-conformances, leading investigations and implementing mitigations
• Represent and cultivate a culture of quality by working with interdisciplinary teams to set expectations, identify gaps, and meet a high internal bar for rigor

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level