DePuy Synthes Companies of Johnson & Johnson is recruiting for a Staff Quality Engineer - New Product
Development, located in Raynham, MA.
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.
DePuy Synthes Spine offers a comprehensive portfolio of spinal care solutions for the treatment of the most
simple to the most complex spine disorders using traditional and minimally invasive techniques.
• Support new product development and design through veri倀cation and validation activities.
• Support design control activities for new product development efforts
• Support maintenance of existing products including but not limited to design changes, process changes, supplier
changes, remediation, recerti倀cation and brand extensions
• Function as a quality lead on multiple product development teams
• Ensure effective and ef倀cient use of risk analysis, test method development, statistical data analysis, and the
development of sample plans
• Develop risk assessment; inspection methodology and acceptance criteria for inspection sample plans and
conduct audits of new suppliers as part of the project teams
• Lead and ensure the development of comprehensive risk management plans for the product, that critical design
information is translated to the manufacturing site and that effective and comprehensive quality
strategies/controls exist for the process
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• Provide leadership in the understanding of medical device regulations to other disciplines.
• Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies
and procedures as well as medical device regulations
• Lead investigation of quality issues and effective corrective and/or preventive action
• Provide people leadership experience as this role may expand to have responsibility for a team of engineersQualifications
• A minimum of a Bachelor's degree in Engineering or Scienti倀c discipline is required, an advanced degree is
• A minimum of 6 years’ experience in a highly regulated industry is required, Medical Device experience preferred.
• Quality engineering experience is required.
• New product development experience is preferred.
• ASQ certi倀cation (CQE, CQM, CRE or CQA) is preferred.
• Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred.
• Six Sigma (Green Belt, Black Belt, lean, etc.) or Process Excellence certi倀cation is highly desired.
• Experience conducting Process/Design Failure Mode Effects and Analysis is an asset.
• Intermediate to advanced knowledge in Statistics, Sampling Planning, Risk Assessment and/or Process
Validation is preferred.
• Prior people management/ mentoring experience is preferred.
• Experience with Blueprint reading/literacy including GD&T is preferred.
• This position will be located in Raynham, MA and require up to 10% domestic and international travel.Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function
Quality (Eng)Requisition ID