BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Quality Engineer II in San Diego, California

Job Description SummaryAs directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For New Product Development activities, 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. For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established BD standards of quality. Successful performance requires close work with quality management, operations, suppliers and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.

Job Description

Responsibilities :

  • Provides critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling and control plans.

  • Applies 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.

  • Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements. I

  • Is an extended team member representing Site Quality on new product development projects and a team member for sustaining engineering projects.

  • Provides audit support (preparation, closure, etc. activities)

  • Establishes a strong working relationship with all levels of operations in order to appropriately monitor and analyze in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control and customer complaint levels in order to take a lead role in identifying and documenting continuous improvement projects.

  • Leads and assures appropriate CAPA activities to accomplish internal/external objectives.

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

  • Design Control (Both New Product Development and Sustaining Processes as applicable)

  • Design Input

  • Design Output

  • Design Verification plans, protocols, and reports

  • Design Reviews

  • Design Validation

  • Design History File support

  • Change control

  • Assessment of Change Request (ACR) Responses

  • Risk Management

  • Process Validations

  • Identification of CTQ's

  • Handling of deviations and non-conformances

  • Test method validations

  • Supplier qualification

  • Software validations

  • Post Market Surveillance Trend Review

  • Situation Analysis

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

  • Proper Use of Statistics (Sampling Plans)

  • Advise on Regulations

  • Provide functional support to cross-functional teams

  • Internal and external audit support

EEO Statement

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.

Primary Work LocationUSA CA - San Diego (BDB)

Additional Locations

Work ShiftNA (United States of America)

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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