Customer Quality


: $151,725.00 - $125,760.00 /year *

Employment Type

: Full-Time


: Healthcare - Physician

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Job Description

DePuySynthes,amember of Johnson & Johnson's Family of Companies, is currently recruitingfor a Customer Quality Investigation Engineer III to be located in WestChester, PA. DePuy Synthes, aspart of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world.DePuy Synthes solutions, in specialties including joint reconstruction, trauma,craniomaxillofacial, spinal surgery and sports medicine, are designed toadvance patient care while delivering clinical and economic value to healthcare systems worldwide. For more information, visit

This Quality role offers exposure to a broad product portfolio. It also provides the opportunity to connect with many company functions. The primary responsibilities of this position include activities associated with conducting complaint investigations including: triage of incoming complaints, documenting requirements for evaluations and investigations, conduct of investigations and communications of performance and safety issues. You will initiate and lead projects involving failure investigations, root cause analysis using appropriate investigative techniques and statistical methods.

Additionally, this Engineer will summarize the results of data analysis and investigations into clear, concise complaint documentation and presentations and reports for peers, multi-functional teams and management. The Customer Quality Investigation Engineer supports business partner processes in post market surveillance, customer quality regulatory reporting, operations/operations quality and new product development. As needed you will be the key interface to ensure escalation of events in a timely manner and per procedure. You will compile data and prepare responses for the US and international regulatory agencies. Close collaboration is needed to provide daily support to the Complaint Teams and ensure complaint investigations are robust and well documented. You may lead training and mentor engineers, provide guidance and direction to peers, and serve as an expert in the investigation process. The Engineer participates on CAPA teams and acting as a CAPA Owner and Internal Audit Observation owner. You would prepare and present training materials for the complaint investigation process. Strong spreadsheet and presentation skills are need to prepare detailed analysis and present complaint information needed for management review and trending. This Engineer represents the complaint unit in Post Market Surveillance reviews.

This position may require up to 10% travel, including light international travel.



  • A minimum of Bachelors Degree in Engineering is required with a preference for Biomedical or Mechanical Engineering.
  • A minimum of 6 years of experience in a Good Manufacturing Practices (GMP) and/or ISO regulated environment.
  • Previous root cause analysis skills.
  • Ability to collaborate with business partners at all levels.
  • Proficiency with Microsoft Office Suite.
  • Excellent communication and presentation skills.
  • Preferences:

  • Medical device industry.
  • Experience conducting and reviewing complaint investigations.
  • Project management experience.
  • Knowledge of process and design excellence tools.
  • Knowledge of CAD software.
  • Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    Associated topics: care physician, family medicine, family practice, family practice physician, physician, physician md, practitioner, primary, provider, urgent * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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