BD (Becton, Dickinson and Company) Quality Engineer II - EU MDR in Franklin Lakes, New Jersey
Job Description Summary
As directed by the Associate Director, the Quality Engineer II is accountable for supporting 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.
Moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools.
Develops solutions to routine problems of moderate scope.
Follows company procedures and makes basic procedural updates.
Developing working knowledge of applicable regulatory, Corporate and/or Unit requirements.
Communicates across functions / departments for assigned areas of responsibility.
Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
Provides audit support (preparation, closure, etc. activities)
Position Overview: Position specific responsibilities include support of the following, however are not limited to:
Design Verification plans, protocols, and report
Design History File support
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
Scope of Responsibility:
Contributes to the completion of milestones associated with specific projects.
Prepares reports, including quantitative / qualitative analysis, summaries and protocols.
Sphere of Influence:
Under general supervision; plans, designs and performs development as assigned.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity
Requires a minimum of a Bachelor’s Degree or equivalent experience
Moderate knowledge of applicable regulatory, Corporate and / or Unit requirements.
Training in statistics. Class II / III medical device experience (preferred). Knowledge of design control principles (preferred). Ability to provide support to internal / external audits.
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience.
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 LocationUSA 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.