Quality Engineer I

Company Info
Collabera
Des Plaines, IL, United States

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Web Site:

Company Profile
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Title:

Quality Engineer I

Location:

Santa Clara, CA 

Salary:

$40.00

Job ID:

78504
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Job Description:

Position Details:

Industry: Medical Device
Job Title: Quality System Engineer
Location: Santa Clara, CA - 95054
Duration: 12 months [+ Possibilities of extension]

Department Description:
  • The Regulatory Affairs Operations (Reg Ops) organization is a divisional function responsible for providing Quality System and Compliance support to the Regulatory Affairs key stakeholders, and to the Business Unit.
  • This support includes maintenance of procedures for the Product Approval Key Process to ensure conformance to regulatory requirements, CAPA – Corrective and Preventive Action investigations, Audit Support (external, internal, corporate), Addendum Labeling controls, Quality Management System and Product Submission Pan-Franchise requests, keeping a pulse on global Emerging Issues and regulatory document management (issuance, archival).

Job responsibilities:
  • This role will provide Quality System and Compliance support to the Regulatory Affairs organization by –
  • Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system
  • Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission
  • Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance’s are met
  • Driving quality system process improvement initiatives. Initiatives include but are not limited to:
    • Establishing emerging issues in our quality system
    • Maintaining the quality system procedures (e.g. change management)
    • Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements
    • Troubleshooting with regulatory affiliates
    • Participating in RA projects. Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
    • Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is needed.