Quality Engineer I
Location:
Warsaw , Indiana
Posted:
February 08, 2017
Reference:
8539170131-en-us

DePuy Synthes Joint Reconstruction, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Quality Engineer located in Warsaw, IN.


DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.


DePuy Synthes Joint Reconstruction is the Orthopaedic division offering a comprehensive portfolio of Orthopaedic Implant solutions for the treatment of the simplest to the most complex joint disorders using traditional and minimally invasive techniques.


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.

Business Improvements
  • 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.
 
Compliance/Regulatory
  • 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.
  • Conduct periodic line audits to assess for production controls such as lot segregation.  Review results of area audits to ensure that corrective and preventive actions are adequate.
 
New Product/Process Introduction
  • Supports new product introduction as part of design transfer.
 

Product Quality, Control & Disposition and Performance Standards

  • Supports activities related to the Material Review Board. 
  • Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.  Escalation of quality issues as appropriate.
  • Review root cause investigation according to an established process.
  • Support the collection/presentation of Quality metrics including leading and lagging indicators of quality
 
Product/Process Qualification
  • Approve IQ, OQ, PQ, TMV or Software Validation
 
Production/Process Controls including Control Plans
  • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. 
  • Working in conjunction with other senior Quality Engineers, reviews effectiveness of current control plans given risk levels.
  • Working in conjunction with other senior Quality Engineers, reviews the level of control in manufacturing processes including the adequacy of current process limits.
 
Risk Mitigation
  • Working in conjunction with other senior Quality Engineers, assess the current risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. 

Qualifications
 
  • 0 - 2 years related work experience. 
  • Knowledge of product/process Risk Management (FDA and ISO standards)
  • Good technical understanding of manufacturing equipment and processes is required.
  • A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field is preferred
  • This position will require relevant experience working in manufacturing/operations. 
  • Experience working in both an FDA and European regulatory environment.
  • Experience with implementation of risk mitigation
  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc. 
  • 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
  • The ability to think on the feet and providing sound judgment
  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise
  • A thorough understanding of GMP/ISO regulations and validation regulations
 
  • This position may require up to 10% travel and will be based in an MD&D manufacturing facility.



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

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