Senior Quality Investigation Engineer

Overview

Johnson & Johnson is seeking a Senior Product Quality Investigation Engineer to join the Product Quality Vigilance organization. The role involves leading, conducting, and supporting investigations of Product Quality Complaints (PQCs) for commercial and clinical products in collaboration with manufacturing sites, quality, and regulatory teams worldwide. You will ensure investigations are complete, scientifically sound, and appropriately documented, and you will support product quality vigilance projects and complaint management processes across the product lifecycle.

• Lead, conduct, and support end-to-end Product Quality Complaint investigations for Janssen combination products and drug products.
• Collaborate with Manufacturing Sites and multi-functional partners to ensure investigations are complete, scientifically sound, and well-documented before complaint closure.
• Serve as a key Product Quality Vigilance contact for assigned manufacturing sites; support investigation activities, escalation, and knowledge transfer.
• Participate in failure investigations, Medical Device Reporting activities, and product trend evaluations.
• Work with Global teams (Manufacturing Sites, Product Development Managers, Contact Centers, Global Medical Safety, Marketing, Sales Administration, Brand Protection, Engineering Quality, Product Quality Management, and others) to strengthen investigation activities and complaint handling.
• Act as a Product Quality Vigilance consultant for complaint investigations and provide guidance on complaint handling requirements and quality system interpretation.
• Coordinate and support failure investigations; assist with Medical Device Report submissions; support site escalations and risk management activities.
• Lead Product Quality Vigilance projects and support new business initiatives to ensure effective knowledge transfer.
• Develop and maintain work instructions and standard operating procedures related to complaint investigations and complaint management.
• Assist with data collection, data correction, data uploads, and other transactional activities related to complaint management.
• Support audits, inspections, and Health Authority requests as needed.
• Identify opportunities to improve investigation methods, complaint management processes, and product knowledge sharing.

• Bachelor’s degree in a technical, scientific, or engineering field required;
  Master’s degree, MBA, or other advanced degree preferred.
• Minimum 5 years of experience in Quality Assurance, Quality Control, Product Quality, or related quality function.
• Experience in pharmaceutical, medical device, or other highly regulated industries; familiarity with complaint management, post-market vigilance, risk management, or compliance is preferred.
• Knowledge of medical safety environments and applicable laws; experience with complaint investigations and quality systems.
• Ability to lead cross-functional projects, influence across sites, and support change initiatives.
• Familiarity with applicable laws and standards (e.g., 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).
• Strong analytical, investigative, and problem-solving skills; effective written and verbal communication.
• Ability to present technical information to multiple levels and departments; ability to build global working relationships.
• Six Sigma Green Belt or equivalent is desirable;
  Black Belt and/or ASQ CQE certification is preferred.
• Understanding of AI concepts and responsible AI practices; ability to use prompting techniques for efficiency is a plus.

We provide a collaborative and inclusive environment where innovation, learning, and professional growth are encouraged. This role offers opportunities to work with global teams and contribute to meaningful quality initiatives that impact patients worldwide.

Johnson & Johnson is an equal opportunity employer. Employment decisions are made without regard to legally protected characteristics. Reasonable accommodations during the application, interview, or onboarding process are available upon request. This role is available across multiple countries and postings may vary by country to comply with local requirements.

Locations mentioned include Italy, Belgium, Ireland, Switzerland, and the US with corresponding requisition numbers. Applications may be submitted across postings and will be considered as a single submission.