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Job Information

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

Job Description Summary

Job Description

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.

Responsibilities

  • 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 Control

  • Design Input

  • Design Output

  • Design Verification plans, protocols, and report

  • 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

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

Qualifications

  • 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.

#LI-PRO

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

Additional Locations

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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.

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