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Senior Quality Systems Specialist - (REMOTE) Palo Alto via Company Shuttle! - WFH during Covid-19

Starts Ready to hire
Duration 6+ Months
Status Freelance (40 hours a week)
Rate $99/hr. - $108/hr. (DOE)
The Bay Area's best-known search engine giant is seeking a Senior Quality Systems Specialist to assist their team.

Top Responsibilities:
-Provide Quality systems expertise toward the ongoing efforts for ISO 13485 Certification in Q3/4 - 2021.
-Lead Auditor of the 21 CFR 820/ISO/MDR based quality management system for internal audits with a strong/working knowledge of Software as a Medical Device (SaMD) product development, deployment and maintenance.
-Provide consulting and advisory services for design control and the software development life cycle process for SaMD.
-Collaborate with key stakeholders in the creation and implementation of corporate level policies.

Ideal Qualifications:
-Bachelor's degree in a scientific discipline or equivalent practical experience.
-7-10 years of experience in the Medical Device Industry associated with Class II or III devices.
-Experience with FDA 21 CFR 820, ISO 13485, IEC 62304, EU MDR, and other international regulations and standards.
-Must have experience with SaMD - Software as a Medical Device or medical devices with software integration.

Submit resume (and samples if applicable) to: Amanda.L.Rielly@jobalert.creativecircle.com

About Creative Circle
Creative Circle is a recruiting agency, and we proudly match professionals with companies looking for talented team members. The above listing is for a role with one of our clients. Our connections at top companies get your resume in front of the right people and access to amazing positions that aren't posted anywhere else. If you’re a good fit for this role (or another we're currently working on), a local recruiter will reach out to schedule a screening interview. We present only the top candidates to our clients.

For Creative Circle to represent candidates for freelance opportunities, applicants must be currently authorized to work in the United States without the need of employer sponsorship for a non-immigrant visa.