Quality Engineer

Not set
United States of America
Palm Coast, Florida
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Sandvik Materials Technology is looking for a Quality Engineer in Palm Coast, FL:

  • Assists the Sandvik Team to ensure effective quality control and associated risk management plans.
  • Assist in writing the Master Validation Plan to define overall Sandvik validation activities
  • Will assist in writing and reviewing process and product validation protocols and reports, equipment qualifications, and engineering process change orders
  • Assist in evaluating and determining the quality of requirements for new product introduction prior to release while assisting in the development, review and approval of process and equipment validation and qualifications (IQ,OQ,PQ,PV) while assuring appropriate testing and statistical methods are utilized, including test method validations
  • Assists in the Failure Mode and Effects Analysis (FMEA) and Control Plans for Process FMEA’s, including appropriate inspection requirements, equipment and gage requirements and sampling plans
  • Supports complaint investigations as appropriate
  • Will assist in Corrective and Preventative Actions (CAPA)
  • Assures proper use of statistical tools to analyze data, make acceptance decisions, and improve process capability (DOE, SPC), throughout the organization
  • Perform Internal audits in accordance with ISO 13485 and ISO9001 standards
  • Assist with external audits (including customer and / or regulatory)
  • Assist in Quality KPI tracking and reporting
  • ISO standard QEHS - All Employees have the responsibility to follow our procedures and to work in a safe and healthy manner. All Employees have the authority to stop activities that threaten our Zero Harm and Right-From-Me policies

Deadline: Not set
Job-ID: R0033606

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