BD (Becton, Dickinson and Company) Service Quality Engineer I in San Diego, California
Job Description SummaryThe Service Quality Engineer I is responsible for the Quality processes within the Service organization, including the Service Depot, Field Service and/or International Service. The Service QE I will be responsible to review the output of Servicing and related Complaint Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement.
Essential Job Functions:
Audit and review Complaint Investigations and records of Servicing activities to ensure they are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system.
Develop investigation criteria and prior investigation summaries
,Conduct analyses of serviced products to identify root causes of failures
Perform Service-related PFMEAs and other activities to support pre-market and post-market risk management activities
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
Participate in Product Transfer teams to assist in developing service repair processes for new or transferred products
Plan, develop and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, inspection method validations,
Participate in the development and review of engineering change orders that impact servicing activities
Work with Engineering to design and implement tooling and fixturing required to perform servicing activities and implement error-proofing (Poke-Yoke) in those stations
Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
Additional Job Functions:
Support the goals of the Quality Organization, Continuous Improvement efforts and Cost Improvement Projects.
Other duties as required.
Excellent technical 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 work with cross-functional teams.
Demonstrated strong attention to detail and “do it right the first time” attitude
Additional Desirable Qualifications Skills and Knowledge:
Knowledge of electro-mechanical troubleshooting techniques
Experience in a customer focused Service organization is a plus
Familiarity with ISO14971 and associated Risk Management Processes is a plus
Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls is a plus
Experience in an FDA regulated environment is a plus
Minimum Education and/or Experience:
Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.)
0-3 years of related quality engineering (QE) work experience
Ability to travel 10-20%
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, or any other protected status.