Contract Technical Writer Resume Troy NY - Hire IT People

AREAS OF EXPERTISE

ISO - 9001/13485/AS9100 Quality Assurance/Auditing Measurement System Analysis Team Management/Collaboration Total Quality Management Systems Root Cause Analysis/ Corrective Actions Process/System Development/Improvement
FDA Compliance
SPC Principles/Techniques
Troubleshooting/evaluation
Computer literate, Confidential Suite
Schematics, blueprints, codes, regulations
Lean, 5S/6S, VSM, TWI, Error Proofing, TPM
Six Sigma tools, DMAIC, PDCA, FMEA, TOC

PROFESSIONAL EXPERIENCE

Contract Technical Writer

Confidential

Responsibilities:

Diverse opportunities which enabled me to expand my knowledge in several areas including FDA compliance, security of personal data, and applications of electronic passive sensor technology. a pharmaceutical company working on migration of SOPs for Oracle upgrade a government agency working on security protocols for NYMMIS an automation sensor manufacturer writing application notes and technology principles

Confidential, Troy NY

VP of Quality

Responsibilities:

Maintained the Quality Management System of a manufacturing organization that included all application development, program planning, quality assurance, and technical documentation, both internal and external
Led the Quality department through the final acceptance stages of two AS9100 qualification projects in compliance with customer requirements
Ensured the department remained in compliance with all applicable standards
Managed ITAR, ESD, COPY EXACT, J-STD's, and IPC requirements

Confidential, Hudson Falls, NY

CONSULTANT

Responsibilities:

Improved the production flow and quality implementation of a medical device manufacture (UV-B Phototherapy)
Updated all production documentation, forms, work instructions, SOP's and processes

Confidential

Quality Associate

Responsibilities:

Developed and maintained QMS procedures for all stages of product realization from design through process development, supplier selection and management, manufacturing, testing and validation and post-release support.
Implemented and maintained document control system.
Documented QMS processes according to quality standards ISO9001 and AS9100.
Monitored internal and external non-conformances, developed containment and preventive actions, communicated results to affected stakeholders.
Aided in identifying resource allocations needed for the successful implementation of the QMS system according to technology roadmaps and program timelines.
Developed and executed internal auditing system.
Trained customer service and new hires on assembly techniques and electrical information. Established stock/ supply levels for panel shop. Designed/fabricated assembly fixtures.
Incoming inspection supervisor for electrical power supply manufacturer
Electrical supervisor with local manufacturer, implemented logistical control and inventory program
Plant Engineer with start-up hybrid electronic manufacturer. Set up/validated manufacturing line, designed 1500 sq ft class 100K clean room, established maintenance, security, procedure protocols.

Confidential, Durham NH

SR. QUALITY ENGINEER

Responsibilities:

Responsible for all mechanical/electrical systems and component parts
Standardized assembly test procedures across divisions
ISO Audit team leader, Product Failure investigation team member
Updated (since 1980's) Quality Assurance Plan; initiated SAP Standardization for MRB
Assisted in Lean MFG, 6S, Value Stream Mapping, and Failure Analysis

QUALITY ENGINEER - Electrical

Confidential

Responsibilities:

Inspected work in process through final acceptance of all electrical systems
Designed/developed test procedures, work instructions and Workmanship Standards
Instructed Assembly on proper electrical techniques and procedures
Managed MRB activities, Corrective Action processes, product improvement programs
Performed UL and CE inspections, Compliance Audits and Post Production Review
Built from print electrical subassemblies and assemblies; updated prints and drawings
Troubleshot finished goods/assemblies and repaired as needed
Developed and initiated product improvements, standardized assembly processes, recommended training strategies and quality improvements