Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America
Job Description:We are searching for the best talent for a
Senior Product Quality Investigation Engineer.
PurposeWe are looking for a Senior Product Quality Investigation Engineer to join our Product Quality Vigilance organization.
Are you interested in solving complex product quality challenges while working with manufacturing, quality, and regulatory teams around the world?
In this role, you will lead, conduct, and support investigations of Product Quality Complaints (PQCs) for commercial and clinical products in close collaboration with manufacturing sites. You will help ensure investigations are complete, scientifically sound, and appropriately documented within the Product Quality Complaint database.
You will evaluate technical information to ensure appropriate analyses, investigations, and failure mode assessments have been performed and documented before complaint closure. The role also supports Product Quality Vigilance projects, new business initiatives, and complaint management processes while serving as a key partner to manufacturing sites and multi-functional teams.
You will be responsible forIn this role, you will lead, conduct, and support Product Quality Complaint investigations for commercial and clinical products. Working closely with manufacturing sites and multi-functional partners, you will help ensure investigations are complete, scientifically sound, and appropriately documented before complaint closure.
You will serve as a key Product Quality Vigilance contact for assigned manufacturing sites, supporting investigation activities, complaint management processes, issue escalation, and product knowledge transfer. The role also includes participation in failure investigations, Medical Device Reporting activities, and product trend evaluations.
You will 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, share product knowledge, and support complaint handling processes throughout the product lifecycle.
Additional responsibilities include:- Serving as a Product Quality Vigilance consultant for complaint investigations
- Leading, conducting, and supporting end-to-end Product Quality Complaint investigations for Janssen combination products and drug products
- Coordinating and supporting failure investigations and assisting with Medical Device Report submissions
- Acting as the Single Point of Contact (SPOC) for Product Quality Vigilance activities with Manufacturing Sites and supporting cross-training activities across sites
- Partnering with Manufacturing Sites to raise awareness of complaint aging, upcoming due dates, prioritization activities, and Medical Device Reporting requirements
- Supporting complaint-related site escalations and communicating site issues and opportunities to end-to-end quality teams
- Participating in signal and trend evaluations related to site products
- Performing statistical and data-based processes to support risk management activities and decision-making
- Supporting transactional activities related to complaint management, including DHR review, data collection, data correction, and data uploads
- Supporting internal and external audits, inspections, and Health Authority requests
- Leading Product Quality Vigilance projects and supporting new business initiatives to ensure effective complaint and knowledge transfer
- Providing guidance on complaint handling requirements and supporting interpretation and implementation of applicable quality system requirements
- Finding opportunities to improve investigation methods, complaint management processes, and product knowledge sharing
- Educating, training, and supporting colleagues on complaint investigation processes, product knowledge, and site-specific processes
- Creating and maintaining work instructions and standard operating procedures related to complaint investigations and complaint management activities
RequirementsWe are looking for someone who combines strong technical expertise with a collaborative approach and a passion for solving product quality challenges.
- Bachelor's degree in a technical, scientific, or engineering field required
- Master's degree, MBA, or other advanced scientific or engineering 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 another highly regulated industry
- Experience in Complaint Management, Post-Market Vigilance, Risk Management, or Compliance is preferred
- Previous project leadership or supervisory experience is 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
- Ability to communicate optimally verbally and in writing
- Ability to present technical information to multiple levels and departments within the organization
- Ability to build strong working relationships in a global environment
- Green Belt (Six Sigma) or equivalent investigation training is desirable
- Black Belt (Six Sigma) and/or ASQ Certified Quality Engineer (CQE) certification is preferred
- Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity
What we offerWe offer a collaborative and inclusive environment where innovation, learning, and professional growth are encouraged. This role provides opportunities to work with global teams, contribute to meaningful quality initiatives, and support products that make a difference for patients around the world.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Italy, Belgium, Ireland - Requisition Number:
R-088867Switzerland - Requisition Number:
R-087278US - Requisition Number:
R-088870Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
#LI-Hybrid
Required Skills: Preferred Skills:Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
