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Quality Engineer

2 months ago

santa clara, United States Intellectt Inc Full time

Role: Quality Engineer

Location: Santa Clara, CA

Duration: 12 Months

Shift Timings: 8 AM – 5 PM


Responsibilities:

Bachelor’s degree. 7+ years’ experience

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.

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.

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.


Interview process: 2 rounds

1st round is with the hiring manager. Teams video.

2nd round will be 2 or 3 people in a panel interview.