Senior Quality Investigation Engineer

Overview

Johnson & Johnson is a global leader in healthcare innovation committed to improving health for humanity.

This role is within the Product Quality Vigilance organization for Senior Product Quality Investigation Engineer, located in Schaffhausen, Switzerland.

Responsibilities

• Lead, conduct, and support investigations of Product Quality Complaints (PQCs) for commercial and clinical products in collaboration with manufacturing sites, quality, and regulatory teams.
• Ensure investigations are complete, scientifically sound, and appropriately documented within the Product Quality Complaint database.
• Evaluate technical information to confirm analyses, investigations, and failure mode assessments are performed and documented before complaint closure.
• Serve as a key Product Quality Vigilance contact for assigned manufacturing sites; support investigation activities, complaint management, issue escalation, and product knowledge transfer.
• Participate in failure investigations, Medical Device Reporting activities, and product trend evaluations.
• 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 support complaint handling across the product lifecycle.
• Lead, conduct, and support end-to-end Product Quality Complaint investigations for Janssen combination products and drug products; coordinate and support failure investigations; assist with Medical Device Report submissions.
• Act as the Single Point of Contact (SPOC) for Product Quality Vigilance activities with Manufacturing Sites and support cross-training across sites.
• Support complaint-related site escalations and communicate issues and opportunities to end-to-end quality teams.
• Participate in signal and trend evaluations related to site products; perform statistical and data-based analyses to support risk management and decision making.
• Support transactional activities related to complaint management, including DHR review, data collection, data correction, and data uploads.
• Support internal and external audits, inspections, and Health Authority requests.
• Lead Product Quality Vigilance projects and support new business initiatives to ensure effective complaint 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, train, and support colleagues on complaint investigation processes, product knowledge, and site-specific processes.
• Create and maintain work instructions and standard operating procedures related to complaint investigations and complaint management activities.

Qualifications

• 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 a related quality function.
• Proven experience within the pharmaceutical, medical device, or other highly regulated industries.
• Experience in Complaint Management, Post-Market Vigilance, Risk Management, or Compliance is preferred.
• Previous project leadership or supervisory experience desirable.
• Knowledge of medical safety environments and applicable laws.
• Experience with complaint investigations, risk management activities, and product quality systems.
• Ability to support change initiatives, project activities, and collaboration across functions and sites.
• Familiarity with applicable laws and standards, including 21 CFR Parts 4, 210, 211, 314, 803, 806, and 820; ISO 13485; ISO 14971; ICH Q10; GDP; GMP; GVP; MEDEV 2.12; CMDR; and Medical Device Directive 93/42/EEC.
• Strong analytical, investigation, and problem-solving skills.
• Excellent verbal and written communication; ability to present technical information to multiple levels and departments.
• Ability to build strong working relationships in a global environment.
• Green Belt (Six Sigma) or equivalent investigation training desirable; Black Belt (Six Sigma) and/or ASQ CQE certification preferred.
• Demonstrates an understanding of AI concepts and frameworks with awareness of responsible and ethical AI practices; uses prompting techniques to support efficiency and productivity.

What we offer

We offer a collaborative and inclusive environment where innovation, learning, and professional growth are encouraged.

This role provides opportunities to work with global teams and contribute to meaningful quality initiatives that impact patients worldwide.

About Johnson & Johnson

Our commitment to inclusion and equal opportunity: We are an equal opportunity employer, and employment decisions are made without regard to legally protected characteristics.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available.

This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

Locations mentioned: Italy, Belgium, Ireland, Switzerland, US. Requisition numbers vary by country; applications will be considered as a single submission.

Note: Do not sell or share personal information where not required.

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