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Principal Quality Engineer III

Job Title:Principal Quality Engineer III
Job ID:7454
Location:Carlsbad CA 92008
Duration:12 Months

Summary of position:
Manage maintaining the sites Quality System, including: developing, establishing and continuously improving site CAPA system, quality assurance programs, quality policies, investigation and trending of quality data streams.
Responsible to drive compliance based programs to ensure the Quality Department supports internal and external customer requirements. Internal customer groups will rely heavily on you to make data driven and highly technical decisions in a timely manner and provide the support necessary to carry out those decisions.

Drive technical and compliance understanding of quality processes associated with quality, CAPA, deviations/exceptions, root cause analysis, change control and quality concepts in a distribution center/commercial office environment.
Manage finished products release and ensure all cGMP requirements are fulfilled for released of finished goods in accordance with regional regulatory requirements.
Review, assist in the development and locally implements relevant SOPs related to Pharmacovigilance (PV), medical device vigilance, product complaint, product recall, medical inquiries, PV agreement with distributors etc.
Based on directives given by product monitoring, coordinates product recalls and provides relevant reports regarding the recalls to regional regulatory authority.

Familiarity with Quality Management Systems, particularly management review and analysis of data requirements.
Above average communicator and collaborator with basic leadership skills.
Proven experience working across functions and geographies.

Bachelors degree in related field.
Preferred: Advanced degree in related technical field.
8+ years of related work experience.
Direct experience with regulatory requirements and quality processes, experience with managing FDA (or Notified Body) inspections.
Software and automated process validation skills a plus. Previous experience managing CAPA process strongly desired.
FDA/ ISO/ GMP knowledge base (ISO 13485 and 21 CFR 820 knowledge a strong plus).
CQIA (ASQ), CQE (ASQ), CSQE (ASQ), and/or Six Sigma Green Belt.
Experience in the medical device or biopharmaceutical industry.

Contact Person: Manju

If you are interested in this position then you can reach me at 2015249600 X 7944
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