Project Engineer Resume

SUMMARY

Self - motivated Quality Engineer / Black Belt proven to effectively utilize improvement techniques to drive continual improvement and demonstrate measureable cost savings while maintaining or improving quality standards.
Background in process improvement and Confidential for Pharmaceuticals, Medical Devices, Automotive, Aerospace and Consumer goods industries.
Actively leads as a change agent in the organization to promote internal and external customer satisfaction.

AREAS OF EXPERTISE:

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Confidential

Project Engineer

Responsibilities:

Generate trend reports within the Consumer Complaints team for the Lincoln facility to identify emerging trends and initiate Deviations, CAPAs and/or Change Controls when necessary.
Develop Annual Product Review / Product Quality Review (APR/PQR) technical complaint summary reports to be included in the APR/PQR report. This includes providing actions taken, recommendations for additional actions and initiating Deviations, CAPAs and/or Change Controls when required.
Investigate and review technical consumer complaints to identify root cause and actions based on the consumer’s complaint.
Authored new documents for trending requirements, including trending thresholds and how to trend for APR/PQRs, the creation / revision of product information within the Consumer Complaint database, and Training Protocols for trending activities.

Confidential

Sr. Quality Engineer

Responsibilities:

Led cross-functional teams to identify causes for warranty returns and initiate corrective actions. Utilizing teardown findings applied Six Sigma tools and techniques to capture savings resulting in $600K to $900K/year.
Analyzed Warranty Returns data and Consumer Call data to identify emerging trends and initiate warranty reduction activities, including corrective actions, of top warranty drivers for focused warranty reduction activities.

Quality Engineer

Confidential

Responsibilities:

Authored and revised primary documents required to update ISO 13485 Quality system and continued maintenance for uninterrupted ISO certification. Performed customer audits and upgraded system to meet FDA requirements.
Developed and Managed Quality Data Systems - managed the formal Corrective Action system driving corrective actions (CAPA) to timely closure with measurable effective actions. Created and managed the Discrepant Material system to provide disposition consensus and compliant material to customers.

Confidential

Quality Manager

Responsibilities:

Implemented ISO 9001, achieved certification in August 2001 through Underwriters Laboratory. Authored and revised all of the documents required for the ISO 9001 implementation
Maintained qualification to military specifications (QPL), by scheduling and overseeing the maintenance (re-qualification) process. Interface with customers to resolve quality issues, perform customer audits and to upgrade the system to meet special customer requirements.

Confidential

Supplier Quality

Responsibilities:

Approved and maintained recommended suppliers: developed and maintained supplier quality performance metrics in easily understood charts and graphs and worked closely with suppliers to improve performance.
Participated in the implementation and maintenance of the ISO 9002 Quality system.

Confidential

Quality Engineer

Responsibilities:

Implemented QS 9000 for the Selective Plating Process used on automotive products and started implementation of ISO 9001 throughout all other departments.
Responsible for implementing, maintaining, training and reporting for the Statistical Process Control program.