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13 дней назад

Product Quality Vigilance, Quality Engineer (MedTech)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Philippines/Belgium
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
Product Quality Vigilance, Quality Engineer (MedTech): Leading investigations of product quality complaints for pharmaceutical and medical device products with an accent on post-market vigilance, failure analysis, regulatory compliance, and data-driven risk management. Focus on improving complaint investigation processes, coordinating manufacturing-site stakeholders, supporting audits and medical device reporting, and delivering technical guidance and training.

Location: Taguig, National Capital Region (Manila), Philippines

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions as part of Johnson & Johnson.

What you will do

  • Lead and support holistic investigations of product quality complaints for commercial and clinical Innovative Medicine products.
  • Evaluate technical analyses, failure modes, root causes, and investigation documentation before complaint closure.
  • Act as the Product Quality Vigilance single point of contact for manufacturing sites and coordinate complaint-related escalations and knowledge transfer.
  • Support failure investigations, Medical Device Report submissions, signal trend evaluations, audits, and inspections.
  • Lead Product Quality Vigilance and new-business projects while partnering with R&D, New Product Introduction, manufacturing, medical safety, quality, and commercial teams.
  • Improve complaint-management methods, create work instructions and standard operating procedures, and deliver training on investigation processes and product knowledge.

Requirements

  • 5+ years of experience in Quality Assurance and/or Quality Control within pharmaceuticals, medical devices, or another highly regulated industry.
  • At least 5 years of related experience in the medical device or pharmaceutical industry.
  • Knowledge of the medical safety environment and regulatory requirements.
  • Experience with project management, change initiatives, cross-functional collaboration, technical writing, and persuasive communication.
  • Bachelor’s degree in a technical, scientific, or engineering discipline.
  • Ability to present to multiple organizational levels and departments.

Nice to have

  • 2.5+ years of experience in complaint management, post-market vigilance, risk management, or compliance.
  • Supervisory experience.
  • Master’s degree or MBA in a technical, scientific, or engineering discipline.
  • Green Belt or Black Belt Six Sigma, CQE certification, or other investigation training.
  • Experience with GAMP, ISO 9001, Lean Supply Chain Management, and quality validation.

Culture & Benefits

  • Full-time employment in a global healthcare organization.
  • Cross-functional collaboration across manufacturing sites and corporate teams.
  • Opportunities to support quality process improvement, training, audits, and regulatory inspections.
  • Inclusive work environment guided by the company’s Credo and focused on employee dignity and diversity.

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