Johnson & Johnson Careers

Associate Value Stream Quality Engineer

Warsaw, Indiana
Quality (Eng)


Job Description

Requisition ID: 5446181025

Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day.  Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.

 

The Associate Quality Engineer under general supervision conducts assignments involving a specific phase of an engineering project which may include design, development, manufacturing, construction, installation, operation and maintenance.  The incumbent may assist in determining objectives and planning schedules of multiple projects with few complex features.
The Associate Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.  This person will support processes in base business.
 
  • Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  • Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  • Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
  • Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.

  • Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.


Qualifications
  • A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 1-2 years related experience. 
  • Experience working in both an FDA and European regulatory environment is preferred.
  • This position will require relevant experience working in manufacturing/operations. 
  • Knowledge of product/process Risk Management (FDA and ISO standards) is required.
  • Experience with implementation of risk mitigation is preferred.
  • Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
  • The ability to perform "hands on" troubleshooting and problem solving is preferred.  The ability to think on the feet and providing sound judgment is highly desired.
  • Good technical understanding of manufacturing equipment and processes is required.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred
  • This position may require up to 10% travel and will be based in an MD&D manufacturing facility.
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.
 

Be VITAL in your career. Be seen for the TALENT you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies. 

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Primary Location
United States-Indiana-Warsaw-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Eng)
Requisition ID
5446181025