BD (Becton, Dickinson and Company) Quality Engineer II in Franklin Lakes, New Jersey

Job Description SummaryAs directed by the Quality Manager, the Quality Engineer II is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product 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.

Job Description

Responsibilities:

  • Consistent application of technical principles, theories, concepts and quality sciences / tools

  • Makes measureable 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:

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 Engineering or Science related field.

  • 2 years relevant experience or a combination of equivalent education and relevant experience

  • Training in statistics. Class II / III medical device experience (preferred). Knowledge of design control principles (preferred). Ability to provide support to internal / external audits.

Primary Work LocationUSA NJ - Franklin Lakes

Additional Locations

Work Shift

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