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.

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

• Design Control   

• Design Input

• Design Output

• Design Verification plans, protocols, and reports

• Design Reviews

• Design Validation

• Design History File support

• Change control

• 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

Strategic Orientation:

• Contributes to the completion of milestones associated with specific projects.

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

• Revises policies/procedures

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.

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

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

Knowledge

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

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.

Education/Degree

Typically requires a minimum of a Bachelor’s Degree

Certifications 

Not applicable.

Experience 

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

#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.

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