BD (Becton, Dickinson and Company) Quality Engineer II in San Diego, California
Job Description SummaryAs directed by the Quality Engineering Leader, the Quality Engineer I is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. In general, this person will understand, improve, and control new product development, operational processes and post market surveillance 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.
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.
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 Overview :
Assessment of Change Request (ACR) Responses
Identification of CTQ's
Handling of deviations and non-conformances
Test method validations
Post Market Surveillance Trend Review
CAPA – Root cause investigation and implementation of corrective / preventive actions
Proper Use of Statistics (Sampling Plans)
Provide functional support to cross-functional teams
Internal and external audit support
Scope of Responsibility:
Contributes to the completion of milestones associated with specific projects.
Prepares reports, including quantitative / qualitative analysis, summaries and protocols.
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.
Training of Associates
Indirect supervision of technicians and other support personnel may be necessary for assigned project completion.
Primary Work LocationUSA CA - San Diego (BDB)
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.