BD (Becton, Dickinson and Company) Staff Quality Engineer I in Franklin Lakes, New Jersey
Job Description Summary
You will combine Design Control expertise, creative problem-solving approaches and strong analytical skills to improve the lives of people with diabetes. I am looking for an experienced engineer (8+ years in medical device) who can mentor junior members of the team and work under consultative direction on major projects and initiatives.
As directed by the Associate Director, the Staff Quality Engineer I will be a member of the BD Medication Delivery Solutions (MDS) - Hypodermic platform and is accountable for 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.
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 History File support
Design Verification plans, protocols, and reports
Assessment of Change Request (ACR) Responses
Identification of CTQ's
Unit Quality Independent Reviewer During Design Reviews
Handling of deviations and non-conformances
Test method validations
Post Market Surveillance
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
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
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.