PURPOSE:
Assists quality engineer in support of the appropriate engineering group, manufacturing, system/services support and materials group. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Assist Quality Engineers in the following activities:
Process validation
Design verification/validation
Product documentation
Statistical Process Control
Product inspection and testing
Qualitative and/or Quantitative data analysis
Continuous Improvement projects
CAPA
Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Associate’s degree in technical discipline (or equivalent).
A minimum of four years experience in a quality/manufacturing related environment.
Understanding/reading of blueprints and process flowcharting.
MicroSoft Ô Office computer software applications literacy.
Demonstrated, working knowledge of basic statistics.
Solid background in Quality Methods and Tools (including mechanical inspection).
Solid knowledge in mechanical inspection tools such as caliper, micrometer, pin gauge usage.
Demonstrated ability to comprehend and execute intricate instructions.
Reading and executing protocols for process /product validations.
Ability to use lab test equipments such as Instron force gauge, vision system and environment conditioning chamber, etc.
Good oral and written communication abilities.
Strong attention to detail.
Team oriented individual.
PREFERRED:
Associate’s degree in technical discipline (or equivalent).
Risk analysis (FMEA) and root cause analysis techniques.
A strong knowledge of GMPs,
Ethics in the workplace and Inspection Methods and techniques.
ASQ – Certified Quality Technician
Boston Scientific Corporation - 13 months ago
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