Identification de l’offre d’emploi R-417538 Date d’affichage 11/02/2021 Retour aux résultats de recherche Postuler

Quality System Specialist III, Complaint Management (Engineer)

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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.

Duties and 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.

Qualifications

  • Consistent application of Quality system standards to assigned Quality system area.

  • Working Knowledge of Quality Systems Regulatory requirements and  application to Company /Unit requirements

  •  Requires a minimum of a Bachelors Degree in Engineering

  • Prefer a minimum 3 - 5 years relevant experience or a combination of equivalent education and relevant experience. 

  •   Understanding of complaint handling, experience with TrackWise preferred. Strong knowledge of Microsoft excel, word and PowerPoint.

Employment at BD is contingent upon the Company's receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

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Primary Work Location

USA IL - Vernon Hills

Additional Locations

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Lieu de l’emploi

Vernon Hills

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Lieu de l’emploi

Vernon Hills

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«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
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