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Quality Engineer II - United States  

Becton Dickinson (company)

Posted on : 22 October 2017

Project Description

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

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

Design Control   

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

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

Requires a minimum of a Bachelor’s Degree.

Primary Work Location

USA UT - Sandy

Additional Locations

Work Shift