BD (Becton, Dickinson and Company) Sr. Quality Manager, Complaints (DCHU) in San Diego, California
Job Description Summary
Under the direction of the Director of Post Market Surveillance, the DCHU Sr. Quality Manager leads a team of Customer Advocacy Specialists and is responsible for the development, implementation and maintenance of processes associated with complaint handling pertaining to the Alaris® infusion pumps.This individual will be responsible for the integrity of the complaint files and the complaint handling process, and will contribute to measurable improvements in complaint handling, product quality, and customer experience.
DUTIES AND RESPONSIBILITIES
-Designs, implements, and maintains complaint handling procedures, including writing requirements and process documentation.
-Serve as a Subject Matter Expert for the complaint handling process.
- Provide complaint handling and quality engineering expertise and consultation to significant / complex projects.
-Lead complaint review board forums, assign investigations to cross functional team members as necessary and monitor completion of tasks
-Escalate incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task owner
-Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions)
-Ensure prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as needed
-Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure
-Participate and support internal, external audits and inspections
-Perform confirmed complaint trending
-Ensure Post Market Surveillance activities are completed
-Performs other related duties and activities as required: project management, presentation creation and strategic planning.
-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 Situational Analysis
- Provide guidance and mentoring to technical investigators during complaint investigations of Alrais® infusion pumps.
Experience and Education
- BS/BA in Engineering discipline or related field
- Experience leading Complaint Handling Team.
- Professional certification is an advantage (e.g., CQA, CQE, SQE, CQM, etc.)
- Minimum of 10 years of progressive experience of quality system management in medical device and high-volume manufacturing environments.
Knowledge and Skills
- Effective oral and written communication skills targetted 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)
- 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).
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.