Our Client, a Medical Device and Healthcare company, is looking for a Quality Engineer IV for their Santa Clara, CA location. Responsibilities: + 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. + Team specifically is operations they do not work on submissions this is why is a QE role and not a RA role. Requirements: + 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 + Independent good clear communication skills, team player, there will be a lot of international cross function interactions. + Good project management skills. + Problem solving expertise. Why Should You Apply? + Health Benefits + Referral Program + Excellent growth and advancement opportunities As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.