1 день назад
Complaint Quality Approver (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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