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BD (Becton, Dickinson and Company) Quality Engineer II - HDS in Franklin Lakes, New Jersey

Job Description Summary

Job Description

As directed by the Quality Sr. Manager, the Quality Engineer II is accountable for supporting new product development and product maintenance on the BD MDS Hazardous Drug Safety (HDS) product platform 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.

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Position specific responsibilities include support of the following, however are not limited to:

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DesignControl

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Design Input

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Design Output

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Design Verification plans, protocols, and reports

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Design Reviews

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Design Validation

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Design History File support

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Change control

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Risk Management

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Process Validations

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Identification of CTQ's

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Unit Quality Independent Reviewer During Design Reviews

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Handling of deviations and non-conformances

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Test method validations

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Supplier qualification

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Software validations

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Post Market Surveillance

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Situation Analysis

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CAPA – Root cause investigation and implementation of corrective / preventive actions

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Proper Use of Statistics (Sampling Plans)

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Advise on Regulations

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Liaise with Manufacturing Plants

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Provide functional support to cross-functional teams

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Internal and external audits

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Strategic Orientation:

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Contributes to the completion of milestones associated with specific projects.

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Prepares reports, including quantitative / qualitative analysis, summaries and protocols.

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Revises policies/procedures

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Sphere of Influence:

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Under general supervision; plans, designs and performs development as assigned.

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Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions to problems with broad scope and complexity.

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Plans and participates in disciplines strategically relevant to the business and/or functions

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May be assigned as extended core team member for sustaining or new product development projects

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Knowledge
Moderate knowledge of applicable medical device and/or pharmaceutical regulatory, Corporate and/or Unit requirements.

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Skills
Training in statistics. Class II / III medical device experience (preferred). Knowledge of design control principles (preferred). Ability to provide support to internal / external audits.

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Education/Degree
Typically requires a minimum of a Bachelor’s Degree

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Certifications
Not applicable.

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Experience
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience in medical device or pharmaceutical industries.

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#LI-PRO

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Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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