Process Engineer, Investigations (CAPA & NC)

Mykelly

Town of Florida (NY)

Presencial

USD 70.000 - 95.000

Jornada completa

Hace 4 días
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Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, 401K
Paid time off
Weekly pay
Kelly Discounts
Professional development opportunities

Descripción de la vacante

Kelly Services is seeking a Process Engineer, Investigations to lead site nonconformance (NC) and CAPA investigations, partnering with Quality Engineering, Operations, R&D, and other groups to resolve quality issues. The role will identify root causes and develop effective corrective and preventive actions with clear documentation to meet regulatory requirements.

The ideal candidate is a detail-oriented problem solver with strong technical writing and collaboration skills and an interest in

Formación

  • Bachelor’s degree in Engineering or a related technical discipline.
  • 1–3 years of experience in medical device manufacturing, aerospace, or a related regulated industry.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work effectively with cross-functional teams.
  • Strong attention to detail and ability to manage multiple priorities.
  • Ability to investigate complex problems, identify root causes, and develop effective corrective actions.

Responsabilidades

  • Lead site nonconformance (NC) and CAPA investigations, including issues related to manufacturing and process performance, calibration, environmental conditions, and product quality and performance.
  • Conduct thorough root-cause investigations using appropriate problem-solving methodologies.
  • Prepare clear, accurate investigation reports and supporting documentation.
  • Define and recommend corrective and preventive actions based on investigation findings.
  • Partner with cross-functional teams to implement and monitor corrective actions.
  • Provide awareness and compliance training to support site quality and regulatory requirements.
  • Collaborate with Quality Engineering, Operations, and other groups to resolve quality issues.
  • Monitor quality metrics related to NCs, CAPAs, and observation actions.
  • Identify opportunities for process improvement and contribute to CI initiatives.

Conocimientos

Analytical skills
Problem solving
Cross-functional collaboration
Attention to detail
Communication skills

Educación

Bachelor’s degree in Engineering

Descripción del empleo

Kelly Services is seeking a Process Engineer, Investigations to lead site nonconformance (NC) and CAPA investigations, partnering with Quality Engineering, Operations, R&D, and other groups to resolve quality issues. The role will identify root causes and develop effective corrective and preventive actions with clear documentation to meet regulatory requirements.

The ideal candidate is a detail-oriented problem solver with strong technical writing and collaboration skills and an interest in

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