Senior Quality Investigation Engineer

Overview

Senior Product Quality Investigation Engineer - Product Quality Vigilance. Lead and support investigations of Product Quality Complaints (PQCs) for commercial and clinical products, working with manufacturing sites, quality, and regulatory teams to ensure investigations are complete, scientifically sound, and well-documented. Collaborate with multifunctional teams to strengthen investigation activities and complaint management throughout the product lifecycle.

Responsibilities

• Lead, conduct, and support end-to-end Product Quality Complaint investigations for Janssen combination products and drug products.
• Coordinate and support failure investigations and assist with Medical Device Report submissions.
• Act as the Single Point of Contact (SPOC) for Product Quality Vigilance activities with Manufacturing Sites; share knowledge and train cross-sites as needed.
• Collaborate with Manufacturing Sites, Product Development Managers, Contact Centers, Global Medical Safety, Marketing, Sales Administration, Brand Protection, Engineering Quality, Product Quality Management, and other partners to strengthen investigation activities and complaint handling.
• Participate in signal and trend evaluations; perform statistical and data-based analyses to support risk management and decision-making.
• Support transactional activities related to complaint management (e.g., DHR review, data collection, data correction, data uploads) and assist with site escalations.
• Support internal and external audits, inspections, and Health Authority requests.
• Lead Product Quality Vigilance projects and support new business initiatives to ensure effective complaint handling and knowledge transfer.
• Provide guidance on complaint handling requirements and interpretation of applicable quality system requirements.
• Identify opportunities to improve investigation methods, complaint management processes, and product knowledge sharing; educate and train colleagues on these processes.
• Create and maintain work instructions and standard operating procedures related to complaint investigations and management activities.

Qualifications

• Bachelor's degree in a technical, scientific, or engineering field required; Master's degree, MBA, or advanced degree preferred.
• Minimum 5 years of experience in Quality Assurance, Quality Control, Product Quality, or a related quality function; pharmaceutical, medical device, or other highly regulated industries experience required or preferred.
• Experience in Complaint Management, Post-Market Vigilance, Risk Management, or Compliance is preferred.
• Knowledge of medical safety environments and applicable laws; familiarity with 21 CFR Parts 4, 210, 211, 314, 803, 806, 820; ISO 13485; ISO 14971; ICH Q10; GDP; GMP; GVP; MEDEV 2.12; CMDR; and Medical Device Directive 93/42/EEC is desirable.
• Strong analytical, investigation, and problem-solving skills; ability to communicate effectively verbally and in writing; able to present technical information to multiple levels and departments.
• Ability to build strong working relationships in a global environment; project leadership or supervisory experience is desirable.
• Green Belt (Six Sigma) or equivalent investigation training desirable; Black Belt (Six Sigma) and/or ASQ CQE certification preferred.
• Demonstrates understanding of AI concepts and responsible AI practices; uses effective prompting techniques to support efficiency and productivity.

What we offer

Collaborative and inclusive environment with opportunities to work with global teams, contribute to meaningful quality initiatives, and support products that improve patient outcomes. Competitive compensation and benefits programs vary by location and are described in the local postings.

Locations

Beerse, Antwerp (Belgium); Latina (Italy); Ringaskiddy, Cork (Ireland); additional country postings may apply.