Job Description Summary

Job Description

As directed by the Senior Manager, the Senior Quality Engineer will be a member of the BD Medication Delivery Solutions (MDS) - Catheter Care platform with a focus on packaging. The Senior Quality Engineer 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 5 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