Senior Quality Engineer

3 days ago


Clearwater, United States CSG Talent Full time

Senior Quality Engineer - Job Description

Responsibilities:

  • Log and investigate customer complaints, assess whether submissions to regulatory agencies are required, and handle customer communications related to complaints.
  • Assist with managing and submitting recalls, Field Safety Notices (FSNs), and adverse event reports.
  • Prepare and present monthly quality trending reports.
  • Coordinate and process nonconformance reports, including logging and investigating issues.
  • Manage the rework process for products to meet quality standards as necessary.
  • Log and manage supplier corrective actions (SCARs), ensuring appropriate follow-up.
  • Coordinate and oversee the calibration of inspection and testing equipment.
  • Conduct supplier evaluations and monitor supplier performance through both on-site (desk audits) and off-site (supplier site) assessments.
  • Maintain and manage external standards indexes.
  • Assist with external and internal quality audits, including those by customers and regulatory authorities.
  • Log and manage Corrective Action/Preventive Action (CAPA) plans.
  • Create product labels for manufacturing processes.
  • Provide support and guidance for change orders, ensuring compliance with quality requirements.
  • Assist with international requests for product registration information.
  • Support regulatory functions as needed, including participating in internal and external audits.
  • Collaborate with Engineering, Manufacturing, Procurement, and Inspection teams to ensure adherence to quality standards.
  • Review and approve Quality System (QS) documents related to New Product Development (NPD), current products, and distributed products.
  • Review and approve engineering protocols and reports as necessary.
  • Monitor, review, and report on environmental conditions within the plant.
  • Review, report, and archive Scrap Reports for analysis and record-keeping.

Location: Clearwater, FL
Work Environment: Onsite
Employment Type: Full-Time



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