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Quality Engineer I
Company Info
Collabera
Des Plaines, IL, United States
Phone:
Web Site:
Company Profile
col-narrow
Title:
Quality Engineer I
Location:
Santa Clara, CA
Salary:
$40.00
Job ID:
78504
col-wide
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.
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