Manufacturing Compliance Specialist

hace 4 días


San Juan, San Juan, Puerto Rico Mentor Technical Group A tiempo completo

Overview of Responsibilities

The Quality Assurance Manager will be responsible for ensuring compliance with FDA, ISO, and internal quality systems regulations.

This includes reviewing plant defect reports, customer complaints, failure investigations, and audit findings to assess manufacturing-related issues that may impact quality.

The manager will also conduct manufacturing non-conformances investigations, customer complaints, CAPA, failure investigations, and audit findings.

They will escalate manufacturing-related issues that may impact quality and recommend courses of corrective action.

The Quality Assurance Manager will participate in regulatory agencies' audits and assist in the investigation of product non-conformances and gather information during regulatory inspections and field actions when required.

The manager will approve or review product investigations reports and perform and report line defects trend analysis, cost of quality, and period quality summaries.

Key Responsibilities
  • Review and analyze data to identify potential quality issues.
  • Investigate and resolve manufacturing-related issues.
  • Develop and implement corrective actions to prevent future issues.
  • Ensure compliance with FDA, ISO, and internal quality systems regulations.
  • Lead and develop a team of associates to ensure effective quality management.

Qualifications and Experience

Bachelor's degree in Engineering (Industrial or CQE preferred).

A minimum of 7 years' experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.

Advanced degree or process towards advanced degree is a plus.



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