BD Nogales Norte
Quality System Specialist III, Complaint Management (Clinical)
BD Nogales Norte, Vernon Hills, Illinois, United States, 60061
Quality System Specialist III, Complaint Management (Clinical)
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Quality System Specialist III, Complaint Management (Clinical)
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BD Nogales Norte Overview
As directed by the Quality Manager, the Quality System Specialist III is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities. Responsibilities
Consistent application of Quality system standards to assigned Quality system area. Develops solutions to routine assigned activities of moderate scope & complexity. Follows applicable Company / Unit procedures and may make updates to procedures and policies. Works within and across functions for assigned Quality systems. Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements. Accountable for setting own work direction and completing work tasks. Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer. Investigate customer complaints for assigned products and processes, including the identification of root causes and contributing factors wherever possible. Recommend corrective and/or preventative action(s) related to customer complaint issues. Identify and monitor patterns and trends in complaint issues related to assigned product groups. Provide a documented report that clearly outlines the investigation process, investigation findings, frequency of related events, corrective actions and recommendations. Develop test protocols and reports where required. Escalate high priority issues as well as identified business risks to the appropriate management level. Escalation of complaints and assist in complaint investigations as required. Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures. Development of Complaint Closure Letters as required. Work with Regional Complaint Centers to resolve and address complaint handling issues. Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports. Development and input to the MDR guidelines to identify failures leading to malfunction reporting requirements. Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements. Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance. Files MedWatch reports after Leader reviews and approves if applicable. Perform other duties as assigned. Additional Responsibilities
Contributes to the completion of specific programs and projects. Develop, implement and follow procedures to ensure timely and accurate receipt documentation, analysis, and response to customer complaints. Contribute to the business-wide Quality strategy and objectives. Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting. Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary. Represent BD MDS on cross-business teams related to Quality Systems. Required Qualifications
Minimum of a Degree in Nursing and/or other Clinical education or a degree in Biomedical engineering. Minimum of 3 years relevant experience in a healthcare setting. Consistent application of Quality system standards to assigned Quality system area. Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements. Understanding of complaint handling, experience with TrackWise preferred. Strong knowledge of Microsoft Excel, Word and PowerPoint. Salary & Benefits
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles. $92,700.00 - $152,900.00 USD Annual Location: USA IL - Vernon Hills. Employment type: Full-time. Seniority level: Mid-Senior level. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where you can learn, grow, and thrive. BD is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics. To learn more about BD, visit https://bd.com/careers Notes: The description may contain locations and roles not currently open; this posting is for reference only.
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Join to apply for the
Quality System Specialist III, Complaint Management (Clinical)
role at
BD Nogales Norte Overview
As directed by the Quality Manager, the Quality System Specialist III is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities. Responsibilities
Consistent application of Quality system standards to assigned Quality system area. Develops solutions to routine assigned activities of moderate scope & complexity. Follows applicable Company / Unit procedures and may make updates to procedures and policies. Works within and across functions for assigned Quality systems. Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements. Accountable for setting own work direction and completing work tasks. Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer. Investigate customer complaints for assigned products and processes, including the identification of root causes and contributing factors wherever possible. Recommend corrective and/or preventative action(s) related to customer complaint issues. Identify and monitor patterns and trends in complaint issues related to assigned product groups. Provide a documented report that clearly outlines the investigation process, investigation findings, frequency of related events, corrective actions and recommendations. Develop test protocols and reports where required. Escalate high priority issues as well as identified business risks to the appropriate management level. Escalation of complaints and assist in complaint investigations as required. Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures. Development of Complaint Closure Letters as required. Work with Regional Complaint Centers to resolve and address complaint handling issues. Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports. Development and input to the MDR guidelines to identify failures leading to malfunction reporting requirements. Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements. Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance. Files MedWatch reports after Leader reviews and approves if applicable. Perform other duties as assigned. Additional Responsibilities
Contributes to the completion of specific programs and projects. Develop, implement and follow procedures to ensure timely and accurate receipt documentation, analysis, and response to customer complaints. Contribute to the business-wide Quality strategy and objectives. Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting. Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary. Represent BD MDS on cross-business teams related to Quality Systems. Required Qualifications
Minimum of a Degree in Nursing and/or other Clinical education or a degree in Biomedical engineering. Minimum of 3 years relevant experience in a healthcare setting. Consistent application of Quality system standards to assigned Quality system area. Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements. Understanding of complaint handling, experience with TrackWise preferred. Strong knowledge of Microsoft Excel, Word and PowerPoint. Salary & Benefits
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles. $92,700.00 - $152,900.00 USD Annual Location: USA IL - Vernon Hills. Employment type: Full-time. Seniority level: Mid-Senior level. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where you can learn, grow, and thrive. BD is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics. To learn more about BD, visit https://bd.com/careers Notes: The description may contain locations and roles not currently open; this posting is for reference only.
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