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Becton, Dickinson and Company

Quality Engineer II

Becton, Dickinson and Company - Franklin Lakes, NJ

Quality Engineer II at Becton Dickinson & CompanyAsset 1

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Quality Engineer II

Job ID R-****** Date posted 03/08/2018

Job Description Summary

As directed by the Quality Manager, the Quality Engineer II 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.

Job Description


- Consistent application of technical principles, theories, concepts and quality sciences / tools

- Makes measureable improvements to BD processes and procedures

- Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements

- Is a team member representing Quality on new product development and sustaining engineering projects

- Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.

- Contributes to the completion of specific programs and projects

- Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers

- Independently determines and develops approach to solution

- May provide guidance and work direction to other team members

- Designs and performs development working independently within defined parameters with minimal supervision required

- Support of the following, however are not limited to:

Design Control

- Design History File support

- Design Validation

- Design Reviews

- Design Verification plans, protocols, and reports

- Design Output

- Design Input

Change control

- Assessment of Change Request (ACR) Responses

- Risk Management

- Process Validations

- Identification of CTQs

- 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


- Bachelors Degree in Engineering or Science related field.

- 2 years relevant experience or a combination of equivalent education and relevant experience

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

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

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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 (************) or email *******************

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9 days 12 hours ago

Becton, Dickinson and Company


Quality Engineer II Becton, Dickinson and Company - Franklin Lakes, NJ, United States


Location: Franklin Lakes, NJ

Company Profile:
BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. BD is headquartered in the United States and has offices in more than 50 countries worldwide.