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1 день назад

Complaint Quality Approver (MedTech)

Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Brazil
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Complaint Quality Approver (MedTech): Independently reviewing and approving complaint investigations for medical products in a regulated quality environment with an accent on evidence-based root cause analysis, risk assessment, data integrity, and cross-site alignment. Focus on challenging investigation gaps, validating corrective actions, and ensuring complete documentation before complaint closure.

Location: Hybrid role in São José dos Campos, São Paulo, Brazil

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across the spectrum of patient care.

What you will do

  • Provide independent Quality review and final approval of complaint records before closure.
  • Evaluate investigation strategies, root cause analyses, supporting evidence, risks, and corrective and preventive actions.
  • Review investigation progress, challenge assumptions, identify gaps, and ensure new information and follow-up actions are documented.
  • Verify data integrity, evidence-based conclusions, trending, recurrence assessments, and cross-site or affiliate alignment.
  • Coach investigation owners on CAPA best practices, system usage, and investigation quality.
  • Work with Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT, other sites, and company affiliates.

Requirements

  • Bachelor’s degree in Life Science or a related discipline, or equivalent experience.
  • 2–4 years of experience performing or reviewing quality investigations, complaints, deviations, nonconformances, or similar quality events.
  • Knowledge of complaint handling, investigations, CAPA concepts, quality systems, and regulatory compliance in a regulated environment.
  • Understanding of cGMP, Good Documentation Practices, and applicable pharmaceutical or medical product regulations.
  • Ability to review technical documents and data, identify inconsistencies, and provide clear, actionable feedback.
  • Strong critical thinking, analytical, organizational, prioritization, and time management skills.

Culture & Benefits

  • Work in a matrixed environment with local and global cross-functional leaders.
  • Collaborate with manufacturing sites and affiliates on investigation strategy and outcomes.
  • Contribute to healthcare innovation and regulated medical technology operations.

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