Quality Assurance Manager

hace 5 días


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

Company Overview

Mentor Technical Group is a world leader in life science engineering and technical solutions. We provide comprehensive portfolios of technical support and solutions for the FDA-regulated industry.

We have offices in various locations, serving clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Job Description

Responsibilities:

  • Review plant defect reports, customer complaints, failure investigations, and audit findings to assess manufacturing-related issues that may impact quality.
  • Conduct manufacturing non-conformances investigations, customer complaints, CAPA, failure investigations, and audit findings.
  • Escalate manufacturing-related issues that may impact quality and recommend courses of corrective action.
  • Participate in regulatory agencies' audits.
  • Assist in the investigation of product non-conformances and gather information during regulatory inspections and field actions when required.
  • Approve or review product investigations reports.
  • Perform and report line defects trend analysis, cost of quality, and period quality summaries.
  • Participate in new product or technology transfers to assess the impact they may have on quality and reliability.
  • Follow up on commitments to FDA and ISO observations for manufacturing-related issues and report trends.
  • Perform quality system audits to determine compliance with FDA, ISO, and internal quality systems regulations.
  • Participate in the development, delivery, and administration of quality training programs.
  • Be an active member in facility continuous improvement initiatives.
  • Provide leadership and guidance to a team of associates, including assigning tasks, setting clear goals, and monitoring performance.

Required Skills and Qualifications

Bachelor's degree in Engineering (Industrial or CQE preferred), advanced degree, or process towards advanced degree is a plus.

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

About Us

Mentor Technical Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



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