BD (Becton, Dickinson and Company) Staff Quality Engineer in San Diego, California
Job Description Summary
As directed by the Quality Manager, the Staff Quality Engineer I 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.
Develop and implement reliability analysis, design, validation and assessment methods to support successful new product introductions and or sustaining product changes
Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies sampling sample sizes and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable
Work with Engineering and R&D to develop reliability testing plus modeling methods specific to products and systems for HALT, Shock and Vibration, Weibull, MTBF and others as required
Lead continuing Test Method Validation and Measurement System Analysis efforts
Leads design for manufacturability and design for assembly activities
Set Reliability goals for products and their subsystems in the field and measure against progress. Maintain a knowledge base of lessons learned to enable continuous improvement
Manage and assess reliability risks that could adversely affect operations by providing analysis, diagnostics, and reporting. This will involve data analysis techniques to help companies meet accepted reliability standards.
Writes detailed Risk Assessments, updates Process Hazard Analysis, and present analysis to the Risk Management Board
Write detailed Design Validation and Verification plans and reports
Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
The role may include creating quality goals and metrics, developing routine tracking mechanism and driving mitigation actions as appropriate. The role may require coaching and mentoring, providing guidance and remove obstacles as needed.
Bachelor’s Degree in Mechanical, Electrical, Reliability Engineering, or related field.
Minimum 10+ years’ experience in quality assurance field in a regulated environment
Minimum 6+ years’ experience in medical device industry
Quality Certification preferred (e.g., CQE)
Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485,ISO14971)
Results orientation with strong written and oral communications skills to lead cross-functional teams.
Ability to effectively lead and influence cross functional teams.
Strong problem identification and problem solving abilities.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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