13 дней назад
Product Quality Vigilance, Quality Engineer (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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