Senior Quality Investigation Engineer

Position

Vollzeit

Senior

Konditionen

Schaffhausen, Switzerland

Anforderungen

5+ J. Erfahrung

Bachelor

EU/EFTA-Bewilligung

Beschreibung

We are searching for the best talent for a Senior Product Quality Investigation Engineer . Purpose We are looking for a Senior Product Quality Investigation Engineer to join our Product Quality Vigilance organization. Are you interested in solving complex product quality challenges while working with manufacturing, quality, and regulatory teams around the world? In this role, you will lead, conduct, and support investigations of Product Quality Complaints (PQCs) for commercial and clinical products in close collaboration with manufacturing sites. You will help ensure investigations are complete, scientifically sound, and appropriately documented within the Product Quality Complaint database. You will evaluate technical information to ensure appropriate analyses, investigations, and failure mode assessments have been performed and documented before complaint closure. The role also supports Product Quality Vigilance projects, new business initiatives, and complaint management processes while serving as a key partner to manufacturing sites and multi-functional teams.

Aufgaben

Lead, conduct, and support Product Quality Complaint investigations for commercial and clinical products.
Ensure investigations are complete, scientifically sound, and appropriately documented before complaint closure.
Serve as a key Product Quality Vigilance contact for assigned manufacturing sites.
Support investigation activities, complaint management processes, issue escalation, and product knowledge transfer.
Participate in failure investigations, Medical Device Reporting activities, and product trend evaluations.
Collaborate with various teams to strengthen investigation activities and support complaint handling processes.

Anforderungen

Bachelor’s degree in a technical, scientific, or engineering field required.
Minimum 5 years of experience in Quality Assurance, Quality Control, Product Quality, or a related quality function.
Proven experience within the pharmaceutical, medical device, or another highly regulated industry.
Experience in Complaint Management, Post-Market Vigilance, Risk Management, or Compliance is preferred.
Strong analytical, investigation, and problem-solving skills.
Ability to communicate optimally verbally and in writing.

Technologien

21 CFR Parts 4, 210, 211, 314, 803, 806, and 820ISO 13485ISO 14971ICH Q10GDPGMPGVPMEDEV 2.12CMDRMedical Device Directive 93/42/EEC

Vorteile

Collaborative and inclusive environment.
Opportunities to work with global teams.
Contribute to meaningful quality initiatives.
Support products that make a difference for patients.

Unternehmen

Johnson & Johnson / Janssen

Healthcare

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.