Senior Quality Engineer, Medical Devices & Compliance

MiniMed Group

Juncos, Northern (PR, KY)

Hybrid

USD 90,000 - 110,000

Full time

4 days ago
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Benefits offered by this job

Short Term Incentive (STI)
Benefits package

Job summary

MiniMed is seeking a Sr Quality Engineer I to join our on-site team in Juncos, Puerto Rico. You will lead investigations, drive corrective actions, and work with engineering and manufacturing to uphold quality and regulatory standards.

You will develop quality protocols, apply statistical methods, and ensure robust documentation. The role emphasizes patient safety and compliant processes in a regulated manufacturing environment.

Qualifications

  • Engineering bachelor degree required.
  • 4+ years of relevant experience or 2 years with advanced degree.
  • Experience with risk management and quality systems preferred.

Responsibilities

  • Lead investigations of nonconformances and drive root cause analysis.
  • Develop and maintain quality standards and inspection processes.
  • Collaborate with engineering and manufacturing to ensure compliance.
  • Design and implement validation strategies and testing methods.
  • Ensure documentation meets regulatory requirements and is audit-ready.

Skills

Quality management
Investigations & root cause analysis
Documentation control
Cross-functional collaboration
Statistical analysis (Minitab)

Education

Engineering Bachelor Degree

Tools

Minitab

Job description

MiniMed is seeking a Sr Quality Engineer I to join our on-site team in Juncos, Puerto Rico. You will lead investigations, drive corrective actions, and work with engineering and manufacturing to uphold quality and regulatory standards.

You will develop quality protocols, apply statistical methods, and ensure robust documentation. The role emphasizes patient safety and compliant processes in a regulated manufacturing environment.

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