Material Quality Engineer- MD Transformation
Location:
Raynham , Massachusetts
Posted:
March 11, 2017
Reference:
3418170301-en-us

DePuy Synthes Orthopaedics is currently searching for a Materials Quality Engineer II at their Raynham, MA facility.

 

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies 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, more agile and better equipped to meet the needs of 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.

The Materials Quality Engineer II will play a key role in developing and implementing raw materials related projects at the Raynham, MA manufacturing facility as part of the cluster Materials Development Team. The successful candidate will apply Quality engineering and process knowledge to relevant manufacturing processes both external and internal to optimize end to end manufacturing in terms of Quality, Service and COGS. This candidate will need to collaborate with the applicable Suppliers, Technology Virtual Teams, SMEs, Source, Procurement, R&D, Engineering and Operations functions in order to be successful identifying and delivering significant materials related engineering projects. 

 

The chosen candidate will be working in a regulated, GxP environment and will need to ensure compliance with the requirements established by the Manufacturing and Quality Engineering groups. This will include working with and around manufacturing equipment, and processes including CNC machining, forging, and investment casting in a highly controlled and validated environment. The ideal candidate must demonstrate a strong ability to recognize, interpret and resolve technical assignments and issues as well as communicate effectively with both internal and external team members.

 
POSITION DUTIES & RESPONSIBILITIES:
  • Develop a high level and understanding of Raynham’s manufacturing processes
  • Participate in the development of long-term strategies for materials related technologies
  • Responsible for writing technical files and reports such as protocols, validation reports, work instructions, change control, and address any potential non-conformances, as well as assist in developing and updating pFMEA documents.
  • Facilitate process risk assessments & FMEA’s
  • Participate in detailed product / process design reviews
  • Quickly develop an understanding and proficiency with the local electronic document management system for the processing of quality related records, procedures, validations and non-conformances
  • Help team to Implement cost effective manufacturing solutions to drive end to end manufacturing efficiencies in partnership with Source and strategic suppliers
  • Work with team on the identification, valuation, planning, organizing, executions, and coordination of quality/value improvement projects at key, strategic raw material suppliers.
  • Assist with feasibility studies to assess new technologies or process improvements
  • Apply appropriate statistical and validation techniques based on overall risk
  • Provide timely and accurate reporting on project activities
  • Ensure all activities comply with GMP, ISO and quality system requirements
  • Ensure that all health, safety and environmental requirements are fulfilled


Qualifications
Required:
  • A minimum of a B.S. in Engineering field required
  • Must have at least two (2) years of overall Quality systems experience within Medical Device or other regulated manufacturing work environment
  • Technical project execution experience
  • Proficiency in MS Office required
  • Ability to read and interpret technical specifications
  • Experience with the creation and execution of validation/verification activities
  • The position is located in Raynham, MA and it is required for the candidate must possess the ability to travel up to 25%
 
Desirable:
 
  • Experience with Risk Management planning and Risk Assessment methodologies
  • History of identifying and delivering significant cost reduction projects
  • Casting, Forging or CNC machining process experience preferred
  • Knowledge of process validations, process mapping and Lean/6 Sigma tools preferred
  • GD&T and process excellence experience preferred 


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

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