Director
Quality Systems
Pacific
Northwest
Ensures compliance
with the FDA's Quality System Requirements and with international
requirements including ISO 13485.
Develops and
implements strategies for implementing the company's quality
objectives through the activities of the department and
cross-functional quality teams.
Develops, implements
and maintains effective quality programs for product design and
manufacturing processes.
Serves as a mentor to
company personnel by training in quality system requirements and the
use of quality tools for continuous process improvement.
Provides counsel to internal departments on quality system
issues.
·
Ensures completed Device History Records are
reviewed for completeness and accuracy and that product released for
distribution meets release criteria.
·
Audits processes for compliance with quality
system requirements and internal procedures, records deficiencies and
ensures corrective actions are developed and implemented.
·
Reviews incoming acceptance activity data,
in-process data, and final inspection data to ensure proper sampling
plans and procedures are employed.
Trends data and works with manufacturing to develop corrective
and preventive actions.
·
Writes procedures necessary for implementing
quality system requirements.
·
Designs and coordinates the execution of
validation protocols. Writes
or reviews final reports.
·
Ensures the coordination of document control and
change control.
·
Performs supplier audits to determine compliance
with quality system requirements.
EDUCATION & EXPERIENCE
B.S. Degree,
preferably in a science or technical field with a minimum of 8 years
experience working in quality systems, or GMP/ISO regulated industry.
Experience in medical device, biologics, or pharmaceutical
industry required.
Experience
in sampling methodology, trend analysis, Statistical Process Control,
Design of Experiments,
Root Cause Analysis, Failure Mode and Effects Analysis or other risk
analysis methodology.
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