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Job Field: Legal Jobs
Location: Mojave, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Position Summary
Quality systems subject matter expert with the
primary responsibility of conducting internal and
supplier audits, assisting with FDA / ISO
inspections, and conducting QSR training.
Develops and compiles monthly reports for
management to track and trend key quality metrics.
Key Responsibilities
Performs internal audits issues audit reports and
follows up to ensure timely closure of audit
findings.
Serves as Quality System expert providing ongoing
guidance and direction to Associates at all levels
in the organization.
Authors quality system changes for ISO 134852003
and other changes for internal or external
requirements as needed.
Advises cross-functional project teams on quality
systems such as FMEA, product development/design
control, supplier quality, and manufacturing
quality.
Conducts/participates in supplier audits. Works
with suppliers to ensure corrective action plans
are developed and implemented for non-conformances
identified.
Tracks and trends key quality indicators and
issues monthly reports. Prepares presentations for
Executive Management Review Meetings.
Assists the QS Manager during external Notified
Body, FDA, etc. audits ensures correction of
identified nonconformities.
Coordinates and performs regularly scheduled
Quality training of all employees.
Minimum Requirements/Qualifications
2  5 years of work experience in Quality Systems
within a regulated environment
Bachelors Degree in a Scientific or related
discipline
Understanding of cGMP and ISO requirements
including previous experience within an IVD or FDA
regulated industry with practical application of
ISO 13485, and FDA Quality System regulations
Problem solving skills with the ability to find
creative solutions that meet regulatory and
business requirements
Ability to provide quality training and deliver
presentations
Excellent communication and interpersonal skills
with the ability to interact with all levels of
the organization and negotiate others
Certified quality systems auditor lead preferred
with prior experience auditing in a regulated
environment

KEY REQUIREMENTS:

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None Bachelors degree