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Staff Quality Systems Specialist I - United States  

Becton Dickinson (company)

Posted on : 22 October 2017

Project Description

As directed by the Senior Quality Manager, the Staff Quality System Specialist I is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities.

Job Description

Core Responsibilities

  • Consistent application of Quality system standards to assigned Quality system area
  • Develops solutions to routine assigned activities of moderate scope & complexity
  • Follows applicable Company / Unit procedures and may make updates to procedures and policies
  • Works within and across functions for assigned Quality systems                              
  • Working Knowledge of Quality Systems Regulatory requirements and  application to Company /Unit requirements
  • Subject Matter expert / Super User at site for assigned quality system
  • Guides the successful completion of major programs and may function in a project leadership role 

Position specific responsibilities include support of the following, however are not limited to:

  • Quality Systems
    • Implement quality system elements required for compliance to the new EU MDR (Medical Device Regulation)  requirements
      • Completion of gap analyses to new requirements
      • Execution of implementation plan to meet new MDR requirements
    • Post Market Surveillance:
      • Develop the global post market surveillance process (PMS) in conjunction with Clinical, Regulatory, and Quality functional representatives
      • Execute the global post market surveillance process in support of EU MDR requirements, including
      • Routine communication with Notified Bodies,
      • Presentation of PMS results to functional stakeholders and Senior Leadership,
      • Follow up to ensure results are translated in to updates to Risk Management documentation and Clinical Evaluation reports as required
    • General:
      • Act as technical expert for EU MDR requirements in support of global sites during external/internal audits
      • Develops training content and provides quality systems related training at Unit and Plant locations
      • Maintains and improves the Unit and WW Quality System documentation
      • Assists with FDA, external, and Corporate audit readiness globally
      • Ensures quality system improvement and standardization initiatives within the business are implemented worldwide


  • Typically requires a BS in a related scientific or engineering discipline and at least 8 years of experience in Quality, Regulatory, or Operations of a Medical Device firm. 


  • Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR, Canadian MDR, Japan PMDA.
  • In-depth understanding of the application of quality systems to the medical device industry.
  • Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Engineer) preferred.
  • Experience in working directly with Notified Bodies and Regulatory Authorities
  • TrackWise, technical writing, auditing experience preferred.
  • Advanced proficiency in data analysis tools such as Excel preferred.
  • Prior experience managing external regulatory audits preferred.
  • Excellent communication skills at all levels both written and verbal.
  • Ability to perform multiple tasks and prioritize work load.
  • Effective analytical, technical, and problem solving skills.
  • Effective meeting and presentation skills.
  • Self-motivated /directed.


Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift