Quality Systems Specialist - III
Quality Systems Specialist - III
Posted on :
27-10-2024
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Job Description
Quality Systems Specialist
Job Location: Remote / Santa Monica California
Job Duration: 12 months
Job Location: Remote / Santa Monica California
Job Duration: 12 months
Description:
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
Mentor QA personnel including organizing and prioritizing daily tasks and performing training.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
May assist with compliance audits as required.
May interface with regulatory agencies as required.
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
Mentor QA personnel including organizing and prioritizing daily tasks and performing training.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
May assist with compliance audits as required.
May interface with regulatory agencies as required.
Experience with Contract Manufacturers
Training & Development
ISO Standards Expertise (ISO 9001 or ISO 13485):
Interfaces with contract manufacturers to address compliance issues related to the quality systems environment.
Continuous Improvement & Lean Six Sigma
Regulatory Interface Experience (FDA EU or Other Agencies)
CAPA (Corrective and Preventive Action) Knowledge:
Supplier Quality Management
Quality Auditing Certifications
Document Control and Change Management
Risk Management Tools (FMEA HACCP)
Quality Software Tools (TrackWise MasterControl etc.)
Regulatory Interface Experience (FDA EU or Other Agencies)
CAPA (Corrective and Preventive Action) Knowledge:
Supplier Quality Management
Quality Auditing Certifications
Document Control and Change Management
Risk Management Tools (FMEA HACCP)
Quality Software Tools (TrackWise MasterControl etc.)
Experience requrired 7 10 years
Employment Type
Full Time
Key Skills
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