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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 validation, design transfer, test method validation, risk management, and specification development.

Job Description

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 will also facilitates design change projects and validation activities for sustaining production products. They will engage in discussions identifying, documenting and reporting quality issues and ensures that each issue is appropriately triaged for continual manufacturability.

Accountabilities:

  • Provide quality leadership to new product development teams in the areas of design transfer, process validations, risk management, and specification development.

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.

  • 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

  • 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

  • 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

Qualifications:

  • 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

#LI-OPS

Primary Work Location

USA CA - San Diego TC Bldg C&D

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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