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Staff Quality Engineer I

Apply Now Job ID R-347749 Date posted 09/11/2019

Job Description Summary

Job Description

As directed by the Senior Manager, the Staff Quality Engineer I will be a member of the BD Medication Delivery Solutions (MDS) - Vascular Management Systems platform with a focus on packaging. The Staff Quality Engineer I is accountable for packaging development and maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from inception through launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Responsibilities:

  • Consistent application of technical principles, theories, concepts and quality sciences / tools
  • Makes measurable improvements to BD processes and procedures
  • Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements
  • Is a team member representing Quality on new product development and sustaining engineering projects
  • Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
  • Contributes to the completion of specific programs and projects
  • Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
  • Independently determines and develops approach to solution
  • May provide guidance and work direction to other team members
  • Designs and performs development working independently within defined parameters with minimal supervision required
  • Support of the following, however are not limited to:

Core Competencies:

  • Design Control
  • Design History File support
  • Design Validation
  • Design Reviews
  • Design Verification plans, protocols, and reports
  • Design Output
  • Design Input
  • Change control
  • Assessment of Change Request (ACR) Responses
  • Risk Management
  • Process Validations
  • Identification of CTQ's
  • Unit Quality Independent Reviewer During Design Reviews
  • Handling of deviations and non-conformances
  • Test method validations
  • Supplier qualification
  • Software validations
  • Post Market Surveillance
  • Situation Analysis
  • CAPA – Root cause investigation and implementation of corrective / preventive actions
  • Proper Use of Statistics (Sampling Plans)
  • Advise on Regulations
  • Liaise with Manufacturing Plants
  • Provide functional support to cross-functional teams
  • Internal and external audits


Qualifications:

  • Bachelor’s Degree in a technical discipline required. 
  • A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience
  • Training in design of experiments and statistics.  Class II / III medical device experience.   Knowledge of six sigma methodology preferred.   Knowledge of design control principles (preferred).  Ability to support internal / external audits.
  • Certified Quality Engineer and Certified Quality Auditor (preferred).

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

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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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com