Becton Dickinson
Senior Quality System Specialist II
Becton Dickinson, Franklin Lakes, New Jersey, United States, 07417
Sr. Quality Systems Specialist - Complaint Management
Under the direction of the Complaint Manager, conducts activities and procedures associated with Specimen Management product complaints. Key responsibilities will include: Accountable for setting own work direction and completing work tasks. Under the direction of the Complaint Manager, the Sr. Quality Systems Specialist - Complaint Management handles activities and procedures associated with Specimen Management product complaints. This person will be accountable for setting their own work direction and completing their work tasks. They will supervise the processing of customer complaints, including maintenance of complaint files, responses to customers, and Quality reports. They will be responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints. As well as supporting Market Segment Teams. This person must be able to lead the end to end process of customer complaints, including utilization of the database systems used to process complaints, and will be responsible for processing of customer complaints specifically Medical Device Reports (MDR's), and complaint reports. Provide mentorship and education regarding customer complaint processing, MDR's, complaint report ability, and regulatory compliance. Fills out decision trees when needed, after appropriate complaint investigation and files MedWatch reports after Leader reviews and approves. Generates MDR reports in accordance with BD procedures and FDA regulations. To be successful in this role, you should be able to demonstrate: Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints. Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures. Provide mentorship, review and generate MDR reports utilizing BD procedures and FDA regulations. Contribute to the business-wide quality strategy and quality objectives Maintain systems to supervise and facilitate the timely investigations and close out of open complaints. Ensure complaints are investigated and completed in a timely manner. Supervise and communicate significant complaint trends, adverse events and other pertinent reports Provides and analyzes organizational quality metrics as required to assess the efficiency of quality system improvements. Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team. Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns on an as needed basis. Ensure the customer complaint investigation, procedures, and activities follow applicable FDA and ISO requirements for complaint handling and adverse event reporting. Exhibit flexibility and resourcefulness by leading assignments in accordance with project priorities and by altering course of action when and where vital Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information. Represents Specimen Management on cross-business teams related to Quality Systems. Partners with other quality professionals to address recurring issues identified throughout the organization. Provides Education: Provides ongoing education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment. Education and competencies required: Education: Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / Engineering field. Experience: 2-3 years of experience in a health care setting where BD or similar products are used, e.g. clinical labs, hospitals, ICU's, health care delivery settings. Three (3) years or more experience in the complaint handling / trending, Medical Device industry, Medical Device Reporting, FDA regulations, GMP, Quality Systems and where applicable clinical and other laboratory functions. Solid understanding of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired Medical device standards and FDA guidance relevant to medical devices. Must have knowledge of product failure modes. Demonstrate competence in mechanical and functional risk assessment. Skills: Strong analytical, deductive reasoning and listening skills High level of problem identification, analysis, and formulation of conceptual / technical and business solutions Ability to deal well with ambiguity Ability to communicate precisely and accurately Strong product knowledge of clinical application usage and/or manufacturing process Effective analytical, technical, and problem-solving skills. Strong project management skills
Under the direction of the Complaint Manager, conducts activities and procedures associated with Specimen Management product complaints. Key responsibilities will include: Accountable for setting own work direction and completing work tasks. Under the direction of the Complaint Manager, the Sr. Quality Systems Specialist - Complaint Management handles activities and procedures associated with Specimen Management product complaints. This person will be accountable for setting their own work direction and completing their work tasks. They will supervise the processing of customer complaints, including maintenance of complaint files, responses to customers, and Quality reports. They will be responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints. As well as supporting Market Segment Teams. This person must be able to lead the end to end process of customer complaints, including utilization of the database systems used to process complaints, and will be responsible for processing of customer complaints specifically Medical Device Reports (MDR's), and complaint reports. Provide mentorship and education regarding customer complaint processing, MDR's, complaint report ability, and regulatory compliance. Fills out decision trees when needed, after appropriate complaint investigation and files MedWatch reports after Leader reviews and approves. Generates MDR reports in accordance with BD procedures and FDA regulations. To be successful in this role, you should be able to demonstrate: Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints. Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures. Provide mentorship, review and generate MDR reports utilizing BD procedures and FDA regulations. Contribute to the business-wide quality strategy and quality objectives Maintain systems to supervise and facilitate the timely investigations and close out of open complaints. Ensure complaints are investigated and completed in a timely manner. Supervise and communicate significant complaint trends, adverse events and other pertinent reports Provides and analyzes organizational quality metrics as required to assess the efficiency of quality system improvements. Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team. Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns on an as needed basis. Ensure the customer complaint investigation, procedures, and activities follow applicable FDA and ISO requirements for complaint handling and adverse event reporting. Exhibit flexibility and resourcefulness by leading assignments in accordance with project priorities and by altering course of action when and where vital Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information. Represents Specimen Management on cross-business teams related to Quality Systems. Partners with other quality professionals to address recurring issues identified throughout the organization. Provides Education: Provides ongoing education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment. Education and competencies required: Education: Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / Engineering field. Experience: 2-3 years of experience in a health care setting where BD or similar products are used, e.g. clinical labs, hospitals, ICU's, health care delivery settings. Three (3) years or more experience in the complaint handling / trending, Medical Device industry, Medical Device Reporting, FDA regulations, GMP, Quality Systems and where applicable clinical and other laboratory functions. Solid understanding of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired Medical device standards and FDA guidance relevant to medical devices. Must have knowledge of product failure modes. Demonstrate competence in mechanical and functional risk assessment. Skills: Strong analytical, deductive reasoning and listening skills High level of problem identification, analysis, and formulation of conceptual / technical and business solutions Ability to deal well with ambiguity Ability to communicate precisely and accurately Strong product knowledge of clinical application usage and/or manufacturing process Effective analytical, technical, and problem-solving skills. Strong project management skills