Quality Vigilance Engineer: Product Quality & Compliance

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a PQV Quality Engineer 4 to lead investigations of Product Quality Complaints (PQC) for Innovative Medicine. You will collaborate with manufacturing, R&D, and cross-functional teams to ensure robust investigations, proper documentation, and risk-managed decision making across sites.

You will act as SPOC for PQV at the site level, support aging/prioritization, and contribute to continuous improvement and compliance with regulatory expectations.

Qualifications

• 5+ years of experience including Quality Assurance and/or Quality Control in pharma/medical device or other highly regulated industries.
• Knowledge of medical safety environment and regulation.
• 5+ years of related experience in Medical Device or Pharmaceutical industry.
• 2.5+ years in Complaint Management, Post Market Vigilance, Risk Management or Compliance preferred.
• Supervisory experience desirable.
• Global mindset and ability for change initiatives, project management, and cross-functional relationships with regulatory knowledge.
• Ability to communicate effectively verbally and in writing; capable of presenting to multiple levels.
• BA/BS in technical, scientific or engineering disciplines; MA/MS/MBA desirable.
• Six Sigma Green Belt desirable or CQE (ASQ) certification preferred.

Responsabilités

• Lead investigations of Innovative Medicine PQCs and ensure documentation in PQC database.
• Coordinate complaint investigations and support for product quality vigilance.
• Interface with manufacturing sites, R&D, and cross-functional teams to ensure product readiness for complaint processes.
• Act as SPOC for PQV at sites and back-up other SPOCs across sites.
• Support audits/inspections and internal quality processes.
• Drive data-driven decisions and improvement initiatives across sites.
• Develop and deliver training on complaint investigation processes and product knowledge.
• Communicate site issues and opportunities to E2E team.

Connaissances

Quality Assurance

Regulatory Knowledge

Data Analysis

Project Management

Communication

Formation

BA/BS in technical, scientific or engineering

MA/MS/MBA in technical, scientific or engineering (desirable)

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
• Solicit customer feedback.
• Educate/Train /Support on Product and Process knowledge relate to site responsible (E2E).
• Create and maintain work instructions and standard operating procedures relative to root cause investigation for complaint management processes.
• Develop and deliver training for colleagues and partners on complaint investigation process, and product specific information.
• Supports the technical writing and provides analytical support in correct investigation outcome interpretation to answer Health Authority Requests related to Complaint Handling.
  
  

Minimum Qualification

• 5+ years of experience including Quality Assurance and/or Quality Control, including experience in Pharmaceutical and/or Medical Device or other related highly regulated industry.
• Knowledge of medical safety environment and regulation.
• 5+ years of related experience in Medical Device or Pharmaceutical industry required.
• 2.5+ years of experience in Complaint Management, Post Market Vigilance, Risk Management or Compliance preferred.
• Supervisory experience desirable.
• Global mindset and demonstrated ability for change initiatives, project management, and develop strong working relationships knowledge of and experience with regulatory requirements
• Ability to communicate effectively verbally and in writing (technical and persuasive).
• Ability to present to multiple levels and department within the organization.
• BA/BS in technical, scientific or engineering disciplines required.
• MA/MS/MBA in technical, scientific or engineering disciplines desirable.
• Green Belt (Six Sigma) desirable or other investigation training required, Black Belt (Six Sigma) CQE (ASQ) certification preferred.
  
  

Required Skills

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy