Job Description Summary

As directed by the Quality Associate Director, the Staff Quality Engineer I is accountable for supporting new product development and product maintenance on the BD MDS HDS platform 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

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

• Design Control   
• Design Input
• Design Output
• Design Verification plans, protocols, and reports
• Design Reviews
• Design Validation
• Design History File support
• 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

Strategic Orientation:

• Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
• Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
• Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives

Sphere of Influence:

• Work is performed without appreciable direction. 
• Assignments are often self-initiated.  Determine and pursue courses of action necessary to obtain desired results.
• Plans and participates in disciplines strategically relevant to the business and/or functions
• Provides advice and mentors junior Associates
• Participates in, and may provide  leadership for, multi-disciplinary projects
• Considered Site / functional level Subject Matter Expert.
• May be assigned  as core team or extended core team member

Knowledge

Extensive knowledge of applicable medical device and/or pharmaceutical regulatory, Corporate and/or Unit requirements.

Skills

Hands on experience in design of experiments and statistics.  Class II / III medical device.  Strong understanding and application of six sigma methodology preferred.  Extensive knowledge of design control principles.  Ability to conduct internal / external Quality Systems audit.

Education/Degree

Requires a minimum of a Bachelor’s Degree in Engineering, Science, or mathematics.

Certifications 

Certified Quality Engineer (preferred).  Certified Quality Auditor (preferred).

Experience 

A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience in medical device or pharmaceutical industries.

#LI-OPS

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