The Fountain Group LLC logo

Quality Engineer

The Fountain Group LLC

  • Santa Clara, CA
  • 30+ days ago
  • $40–$53 Per Hour
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Skills

  • Code of Federal Regulationsunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • ISO (International Organization for Standardization)unmatched
  • Medical Equipmentunmatched
  • Mergers and Acquisitionsunmatched
  • Operational Supportunmatched
  • Performance Metricsunmatched
  • Quality Engineeringunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Reporting Dashboardsunmatched
  • Risk Managementunmatched
  • System Integration (SI)unmatched
  • Systems Administration/Managementunmatched

Description

The Fountain Group is currently seeking a ­­­­­­­­Quality Engineer for a prominent client of ours. This position is located in ­­Santa Clara, CA. Details for the position are as follows:

Pay Range: $40 - 53/hr depending on experience
W2 Contract: 1 year with possible extension and/or conversion
100% onsite in Santa Clara, CA

Job Description:

  • Join the Regulatory Operations Team, supporting them from Quality Systems + Compliance perspective – supporting Audits, owning CAPA’s, labeling controls in Quality System, managing KPI’s to ensure Regulatory processes are healthy. 
  • Will work on a few key projects – managing KPI dashboard reflecting health of Regulatory Quality system, and currently integrating a Quality System from a company acquisition – so at the product approval process.  Experience supporting Audits would be great as we’ll work on Audit preparedness – risk mitigation activities such as implementing mock audits for key regulatory documents.  
  • Team does a lot of investigational activities for CAPA’s and NCMR’s, determining mitigation strategies. 

Qualifications:

  • Senior Quality background – Quality Systems requirements, Quality Systems compliance activities in Medical Device – ISO 13485, 21 CFR Part 800, EU MDR etc
  • Bachelor's Degree in technical discipline

If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at 813-356-0199.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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Numbers & Facts

LocationSanta Clara, CA
IndustryStaffing/Employment Agencies
Salary$40–$53 Per Hour
Company Size500 to 999 employees
Websitehttps://www.thefountaingroup.com/

About Company

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

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