BD (Becton, Dickinson and Company) Staff. Quality Engineer, Service Depot in San Diego, California
Job Description Summary
The Staff Quality Engineer, Service Depot is responsible for the quality processes within the service organization, specifically for the Service Depot. The Staff Quality Engineer, Service Depot will be responsible to review the output of servicing and related complaint investigation activities to ensure that the resulting work complies with all regulatory requirements, as well as advancing facility, divisional, and corporate objectives for defect prevention and continuous improvement.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Essential Job Functions:
Ensure that complaint investigations and records of servicing activities are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system.
Assist technicians in establishing investigation criteria and, as needed in troubleshooting returned products to identify root causes of failures.
Coordinate and perform quality trending of service data and conduct investigations to identify causes of servicing and service-related complaint trends, including issues in servicing workmanship and Out of Box failures.
Provide ongoing training to service staff on regulatory requirements associated with complaint investigations and Servicing records.
Plan, develop and conduct service manual and service work instruction validations (IQ, OQ, PQ), test method validations, inspection method validations.
Leads cross-functional reviews of all Depot related activities such as depot repair, RMA’s, turnaround time, quality trends, supplier issues, and KPI’s.
Facilitates communications, team meetings, continuous improvement, and calibration activities.
Works collaboratively with all constituents to ensure quality and service-related goals are achieved.
Review and approve completed service records for accuracy.
Additional Job Functions:
Support of data entry associated with complaint investigations which streamlines root/cause and corrective actions associated with quality issues.
Work closely with service leadership to ensure adequate training and quality support is being provided to improve data capture and quality actions to improve the customer experience.
Conducts process and product audits to confirm compliance with company policies.
Participates in special projects as required.
Support the goals of the Quality Organization, Continuous Improvement efforts and Cost Improvement Projects.
Other duties as required.
Excellent technical and analytical report writing skills.
Strong Root Cause Analysis and Design Of Experiments/Investigation experience as related to service activities and complaint investigations.
A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.
Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.).
Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills.
A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.
Strong focus on meeting customer needs.
Ability to train/mentor direct reports of Quality Engineers and Quality Inspectors.
Ability to work with cross-functional teams.
Demonstrated strong attention to detail and “do it right the first time” attitude.
Qualifications, Skills, and Knowledge:
Experience in electro-mechanical troubleshooting techniques.
Experience in a customer focused Service organization.
Familiarity with ISO14971 and associated Risk Management Processes.
Comprehensive knowledge of quality assurance and continuous improvement concepts, procedures, and processes.
Experience in an FDA regulated environment is a plus.
Ability to work with and motivate people.
Proven leadership skills in a fast pace environment.
Total quality management, six sigma or other quality affiliated training and/or certification is preferred.
Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.).
5 years of experience in Quality Engineering or related field.
For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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 Location
USA CA - San Diego TC Bldg C&D