BD (Becton, Dickinson and Company) Staff Quality Engineer I in Franklin Lakes, New Jersey
Job Description SummaryAs directed by the Sr. Quality Manager, the Staff Quality Engineer I 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.
Responsibilities and Duties:
Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measureable / confirmed results.
Track record of root cause determination and effective corrective / preventive action implementation.
Provides training for product development teams and continuous improvement team on best practices.
Conducts audits as member of a quality system audit team (e.g. SME, etc.)
Writes and leads risk management activities including risk management reports and risk analyses.
Scope of Responsibility:
Guides the successful completion of major programs and may function in a project leadership role.
Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations.
Decisions, recommendations and results further the achievement of goals critical to organizational objectives
Implements and communicates the strategic and technical direction for the product/project team
Identifies any issues that may delay product or project and recommends appropriate action to be taken
Position Specific Overview: Position specific responsibilities include support of the following, however are not limited to:
Design Verification plans, protocols, and reports
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
Typically requires a minimum of a Bachelor’s Degree
Certified Quality Engineer and Certified Quality Auditor (preferred).
A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience.
- Extensive knowledge of applicable regulatory, Corporate and / or Unit requirements.
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.
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