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Support the Manufacturing, Materials Group and Quality department as required in all aspects of inventory management, quality control, quality assurance and regulatory compliance activities.
Job Responsibility:
Contribute to a positive, high-performance team environment
Provide support to manufacturing and purchasing through inspection and auditing of incoming material for conformance to product specification, purchasing specifications, as well as Food and Drug Administration to GMPs and ISO 13485
Performs timely First Article Inspections, and Incoming Inspections using mechanical and measuring equipment to ensure conformance to part/product specifications and requirements
Maintain control of equipment requiring calibration and preventative maintenance
Coordinate calibration of equipment with manufacturing engineers and procurement team
Coordinate preventative maintenance work with manufacturing engineers
Maintain control of materials used in manufacturing
Prepare and review shipment of product to sterilization
Actively supports quality control and continuous improvement through participation in engineering changes and other improvement programs
Will also assist in supplier evaluation through data collection of inspection results
May be required to do special testing, engineering support work, and other quality control and quality assurance activities
Writes first article inspections, incoming inspections, work instructions, procedures, and special instructions as required
Assists in In-process/Final Inspection as required
Take on special assignments as warranted
Work with receiving, finance and purchasing to reconcile discrepancies in receiving and invoicing
Adheres to and supports the Quality Policy as well as all ISO-13485 Quality System procedures and guidelines
Maintain Metrics
Support Lean activities and initiatives
Support EHS activities and initiatives
May be asked to handle some shipping and receiving tasks
Perform other duties/special projects as assigned
Requirements:
College or University Degree or at least 3 years of experience with inspecting parts using measurement equipment in an ISO 9001 environment
Exposure to ISO 9001 quality system minimum
Preferred, exposure to ISO 13485 standard
Ability to read and understand part drawings and written specifications
Ability to interpret technical drawings, dimensions, tolerances, etc
Ability to interpret circuit schematics
Employs a results-oriented work style and teamwork-oriented approach to meeting objectives
Demonstrates the ability to prioritize duties, multi-task, and quickly assume new tasks to function productively in a fast-paced environment
Proven ability to establish working relationships with design engineers, sustaining engineers, manufacturing engineers, production technicians, procurement team, QC personnel, and QA personnel
Strong communication skills, written and oral
Possess excellent attention to detail to ensure accuracy