BD (Becton, Dickinson and Company) Jobs

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

Job Description SummaryAs directed by the Quality Engineering Leader, the Sr. Quality Engineer 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 :

  • Applies consistent application of technical principles, theories, concepts and quality sciences / tools.

  • Applies strong problem solving skills including supporting complex issues.

  • 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.

  • Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices.

  • Writes and leads risk management activities including risk management reports and risk analysis.

  • May serve as Site Validation Leader

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

  • Assessment of Change Request (ACR) Responses

  • Risk Management

  • Process Validations

  • Identification of CTQ's

  • Site 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 Unit and Corporate functions on policies and procedures

  • Provide functional support to cross-functional teams

  • Internal and external audits

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 Shift

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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