San Diego, California, JOB SUMMARY
Under the direction of the Director of Post Market Quality, the Sr. Quality Manager Complaint Investigations leads a team of Quality Engineers and Technicians and is responsible for the development, implementation and maintenance of processes associated with complaint investigations pertaining to the Alaris® infusion pumps. This individual will be responsible for the integrity of the complaint investigations and ensure that investigation conclusions are clear, supported, robust and compliant. This individual will establish best practices in complaint investigation processes for a large volume of complaints and associated root cause determination protocols and testing methodologies. Additionally, this individual must have strong analytical skills and effective communication across all levels of the company and demonstrate strong teamwork and collaboration across several functional areas to drive continuous product improvements.
Job Description
DUTIES AND RESPONSIBILITIES
Designs, implements, and maintains complaint investigation processes and procedures, including writing requirements and process documentation.
Ability to solve complex problems by developing novel failure investigation test methodologies and associated processes and training materials.
Serve as a Subject Matter Expert for complaint investigations which includes both internal functional support and external customer support with respect to complaint investigation findings and associated improvements initiatives.
Provide complaint investigation and quality engineering expertise and consultation to significant / complex projects.
Ensure timely completion of complaint failure investigations and communicate with management and team members as required to ensure appropriate actions are taken to maintain/restore timeliness goals.
Ensure all complaint investigations failures have been adequately risk-assessed and initiate and champion new risk assessments as required.
Performed audit remediation of the complaint process as part of on-going FDA compliance activities and 483 corrective actions.
Own and/or lead investigations and root cause analysis efforts for Corrective and Preventive Actions (CAPAs) when necessary.
Develop, compile and present complaint investigation process summary metrics to Senior and Executive Management, as necessary.
Communicates complaint investigation findings to appropriate personnel and escalates to Senior Management on critical issues as necessary.
Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).
Ensure complaint investigation documentation and records are complete and in compliance with regulatory requirements.
Participate and support internal, external audits and inspections as needed.
Performs other related duties and activities as required: project management, resource assessments, presentation creation and strategic planning.
Manages and coordinates the complaint investigation team and associates who exercise responsibility for results in terms of investigation accuracy, completion time, and documentation. Areas of responsibility include Customer Complaint Investigations and associated complaint investigation metrics.
Implements processes for handling a large volume of complaints incoming through global locations, depot and field service records.
Identifies and implements efficiency and compliance improvements to the complaint investigation process.
Ability to link CAPA or other failure investigations to complaint records.
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 with respect to complaint investigations.
Assures all relevant complaints are escalated to Risk Analysis and/or Situational Analysis
Provide guidance and mentoring to complaint investigation team to ensure investigation best-practices are implemented and utilized during complaint investigations of Alaris® infusion pumps
MINIMUM QUALIFICATIONS
Experience and Education
BS/BA in Engineering discipline or related field.
Experience leading and building a strong Failure Investigation or CAPA team.
Professional certification is an advantage (e.g., CQE, CRE, Lean Six Sigma, Six Sigma Black Belt, etc)
Minimum of 10 years of progressive experience leading failure investigation teams and demonstrated history of effective root cause determination in complex electro-mechanical, software-driven medical devices in a high-volume manufacturing environment.
Must possess solid background of establishing new failure investigation processes, test protocols, and procedures.
Knowledge and Skills
Effective oral and written communication skills targeted at all levels within the company.
Experience in supervision of or in working with a product/component failure analysis lab.
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.
Demonstrated knowledge of implementing new test methods and associated validation strategy and documentation.
Project management utilizing analytical, technical, and problem-solving skills. Able to perform multiple complex tasks/projects and prioritize workloads and activities for large volumes of complaints.
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 authorities at inspections regarding failure investigation activities (prior experiencing as failure investigation SME during inspections is a must).
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.