Job Information
BD (Becton, Dickinson and Company) Staff Quality Engineer - Medication Delivery Systems in Franklin Lakes, New Jersey
Job Description Summary
Job Description
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Summary - Main Purpose of the Position
As 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.
Primary Responsibilities and Dutie s:
Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / 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.
May perform other duties as required.
Position-Specific Overview: Position specific responsibilities include support of the following, however are not limited to:
Design Controls
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
KSA Requirements (Knowledge, Skills, and Abilities):
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.
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.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
PDN
Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
Work Shift
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.