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Developed retrospective DHF/DMR documentation, manufacturing work
instructions and verification and validation test reports and protocols
for $500M medical device client.
Translated user requirements to engineering specifications
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Developed translation rationales (Phase 1 documentation) for implantable
product projects for a large medical device corporation
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Documented and summarized Voice of the Customer data for new product
development project
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Developed and implemented ISO9001 compliant Quality System for a small
to mid-size company; acted as Management Representative and Document
Control Coordinator; trained company employees on relevant policies,
procedures and work instructions; conducted and scheduled internal and
quality supplier audits
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Established and managed a Vendor Rating System to monitor vendor
delivery and quality performance; worked closely with vendors to improve
manufacturing and inspection processes
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Implemented a Corrective Action Procedure to proactively prevent repeat
discrepancies; acted as Material Review Chairperson and managed a
multi-functional team to review discrepancies and implement necessary
improvements
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Managed customer returns and repair analyses and coordinated feedback to
customers; conducted field failure investigations and provided
corrective actions; monitored and reported quality trends
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Developed and implemented inspection and documentation procedures in
manufacturing departments in accordance with product specifications;
initiated improvements in manufacturing and quality processes for
ISO9001 compliance
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Managed all quality assurance functions within a company; supervised the
activities of two quality control technicians and receiving inspector
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Reviewed and approved product test methods, specifications and drawings
in accordance with ISO and company procedures
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Provided quality engineering support to manufacturing sites; performed
quality control testing and inspection of raw materials, work in process
and finished goods; responsible for calibration scheduling and
maintenance of calibration records
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