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Supervisor, Customer Advocacy Tech

Apply Now Job ID R-346497 Date posted 09/04/2019

Locations

San Diego, California

Job Description Summary

Under the direction of the Customer Advocacy Technical Manager, the Customer Advocacy Tech Supervisor is responsible for the development, implementation and maintenance of the technical complaint investigation processes of Alaris® infusion pumps. Oversees activities related to failure investigation such as device assessment, troubleshooting, pertinent root cause analysis and report writing. Identifies improvement opportunities and partners with R&D, Quality, Regulatory and Service/Repair department to improve product quality. Interacts with BD customer facing departments and customers to resolve customer needs related to complaint investigations.

Job Description

Duties and Responsibilities:

  • Manages and coordinates the Complaint Department and associates who exercise responsibility for results in terms of investigation accuracy, completion time, and documentation.  Areas of responsibility include Customer Complaints and complaint metrics.
  • Establishes and delegates operational goals, objectives and assignments. Formulates and implements policies and procedures to carry out the BD quality goals in support of the BD quality policy and quality system on a worldwide basis.
  • Identifies and implements efficiency and compliance improvements to the complaint investigation process.
  • Participates in external regulatory inspections. Ensures that pre and post-inspection activities are completed including record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management.
  • Manages the customer complaint system within BD that includes timely submission of product related investigations, reports, documentation, and communication to BD customers and responsible BDB and Corporate departments.  Ensures all complaints are assessed for reportability to the FDA and all applicable worldwide governing bodies.
  • Assures all relevant complaints are escalated to Risk Analysis and/or Health Hazard Evaluation.
  • Provide guidance and mentoring to technical investigators during complaint investigations of Alrais® infusion pumps.

Qualifications

Minimum Knowledge and Skills:

  • Effective oral and written communication skills targeted at all levels within the company.  
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.
  • Project management utilizing analytical, technical, and problem-solving skills.  Able to perform multiple complex tasks/projects and prioritize workloads and activities.
  • Strong organizational skills and demonstrated ability to meet tight deadlines in an environment of competing priorities.
  • Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise, a plus)
  • Extensive knowledge of FDA Quality Systems Regulations 21 CFR Part 820, Medical Device Reporting 21 CFR 803, Report of Corrections and Removals 21 CFR 806,  ISO 13485 Quality Management Systems Medical Devices, ISO 14971 Risk Management.
  • International Regulations for Medical Devices e.g. but not limited to: EU Medical Device Regulation (MDR), Canada SOR/98-282 Medical Device Regulations.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is a must).
  • Hands on experience in disassembling, troubleshooting and testing electromechanical medical devices preferably infusion pumps.

Education and Experience:

  • BS/BA in Engineering discipline or related field.
  • Experience leading Quality, Regulatory or Complaint Investigators Team.
  • Professional certification is an advantage (e.g., CQA, CQE, SQE, CQM, etc.)
  • Minimum of 5 years of progressively more responsible experience of quality system management in medical device and high-volume manufacturing environments.

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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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