Quality Engineer IV"

Spectraforce Technologies
United States, California, Santa Clara
Mar 27, 2025
Job Title - Quality Engineer IV Location - Santa Clara, CA, 95054 Duration: 12 Months + Must have medical device. Familiar with regulations for Regulatory Affairs Someone who can hit the ground running or have supported the overall quality system. This role supports audits for the organization. Bachelor's degree 7+ years' experience Her team is rather unique. They are part of the Regulatory Affairs organization. They support their RA organization and their business unit from a quality and compliance perspective. Looking for someone with quality systems experience who has senior level expertise. Activities they do is supporting audits for RA manage all CAPA's for RA organization. Key task for this role is putting together a KPI dashboard maintaining that from a compliance perspective to keep a pule on metrics that they have. Highlight risks if they see them and put in mitigation plans before they become audit findings or nonconforming results in CAPA related activities. Her team specifically is operations they do not work on submissions this is why is a QE role and not a RA role. Supports management and creation of the processes that allows the RA specialist to execute those submission requirements. Soft skills Independent good clear communication skills, team player, there will be a lot of international cross function interactions. Good project management skills. Problem solving expertise.