BD (Becton, Dickinson and Company) Staff Quality Validation Engineer in San Diego, California
Job Description Summary
Quality Engineering is a fast paced, dynamic environment requiring decision making at the strategic and tactical levels. The job requires a highly motivated self-starter with an ability to work with minimal supervision in a team environment.
This role will serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability. Requires strong quality leadership to product development/sustaining teams in the areas of design transfer, validation, risk management, and specification development.
Position 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. This person facilitates validation activities for sustaining production products, facilities, utilities, equipment and process. They will engage in discussions identifying, documenting and reporting quality issues and ensures that each issue is appropriately triaged for continual manufacturability.
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.
Provide quality leadership to new product development teams in the areas of validation (IQ, OQ, PQ, TMV etc) and design transfer, risk management, and specification development.
Responsible for reviewing qualification and validation protocols for facilities utilities equipment and computerized systems. resolves protocol discrepancies and deviations. supports change control
Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Create, populate and maintain data for tracking validation activities, test results and validate systems
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 and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable
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
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
Support successful new product introductions and or sustaining product changes
Maintain a knowledge base of lessons learned to enable continuous improvement
Understanding of measurement uncertainties and measurement system analysis
Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or related.
Minimum 8+ 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 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
Primary Work Location
USA 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, or any other protected status.