Product Quality Vigilance, Quality Engineer

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. Job Function: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Beerse, Antwerp, Belgium, Taguig, National Capital Region (Manila), Philippines, Turnhout, Antwerp, Belgium Job Description: Essential Job Duties and Responsibilities PQV Quality Engineer 4 will be responsible to lead, conduct and support investigation of Innovative Medicine Product Quality Complaints (PQCs) for commercial and clinical products in close cooperation with the manufacturing sites, and to ensure a complete holistic: Investigation for PQCs is documented in PQC database. Evaluates information from technical perspective to ensure appropriate analysis, investigation and failure modes have been executed and documented prior complaint closure. Leads Product Quality Vigilance projects and new business projects to ensure complaint and effective data/ knowledge transfer. Collaborates across departments and sites and be the liaison with R&D and New Product Introduction team to ensure new products readiness for complaint vigilance quality process support and other functions. Site PQV consultant for investigations. Lead, conduct and support holistic complaint investigations support for Innovative Medicine Drug Products Coordinate and support Failure investigations and assist in the processes for submission of Medical Device Reports. Act as Single Point of Contact (SPOC) of PQV for Manufacturing Sites. Back-up other SPOCS (cross train on other site products and processes). Partner with Site to raise awareness of Aging/coming due/prioritization Involved with Complaint related site escalations (aware all escalation to see if any impact to future complaints). Communication of sites issues and opportunities to E2E Team. Execute statistical / data-driven processes and documentation to support controlled risk management and decision making. Ensures appropriate statistical/data-driven decision making is incorporated into processes. Participate in signal trend evaluations relate to site products (involvement). Partner with customers (Manufacturing Sites, PDMs, Contact Center (LOCs), Global Medical Safety, Marketing, Sales Administration, Brand Protection, EQ, PQM, etc.) to gain knowledge of products and processes. Improve existing methods and processes for conducting product investigations. Evaluate information from a technical perspective to ensure appropriate analysis, investigation and failures modes have been analyzed and documented prior to complaint closure. Execute transactional tasks to support complaint management process (data collection/correction/ upload, etc.) Support internal and external audits and inspections. Lead project for Product Quality Vigilance, collaborate across departments and sites. Actively manage consumer relationships (with manufacturing sites, LOC´s, Product Quality Management, GMS, JJQS, IT, etc.). Provide guidance and expertise to internal and external partners for the interpretation, implementation, and execution of QSR requirements related to product complaint investigation. Drive technical and process improvement and influence change.