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Staff Quality Systems Specialist I (Team Lead - Designated Complaint Handling Unit)

Apply Now Job ID R-357062 Date posted 01/13/2020

Locations

Franklin Lakes, New Jersey

Job Description Summary

The Staff Quality Systems Specialist I is a team leader for the DCHU (Designated Complaint Handling Unit) in Quality Systems. In this role, the team lead provides quality and/or technical leadership to product/projects/systems, as well as, accountability to process complaints for the assigned product platform, including but not limited to, kicking off decision tree tasks where applicable and providing feedback and support to the Adverse Event Group on MDR related activities. Directly accountable for multiple projects within the department or has accountability for programs across multiple plants.

Conceptualizes, prioritizes and schedules other project deliverables within Quality Systems. Determines feasibility of project features, deliverables and resource availability to recommend viable options. Leads continuous improvement activities for the DS Quality System.

Job Description

Accountabilities: 

  • Collects, interprets and analyzes data and presents to others either orally or in writing.  Understands and leverages published Quality System and regulatory agency requirements and leverages best practices.  Makes recommendations for project direction including alternative solutions. 
  • Readily applies Quality System principles to the solution of complex technical problems.
  • Acts independently, consults with supervisor on unusual situations.
  • May train, develop or assign work to others; provides technical and or supervisory guidance to others.  May be responsible for on contribute to the assessment and development of DCHU associates who report directly to the Senior Manager of Quality Systems.
  • Responsible for the creation of quality system programs for IDS in topics that need increased awareness and visibility. Needs assessments, management input, corporate initiatives, and FDA focus will be factors in planning the strategy/priorities for such programs. Project may be part of continuous improvement (i.e. preventive action, best practices) or as part of a corrective actions.
  • Represents IDS on cross-business teams related to Quality Systems.
  • Functions on corporate initiated teams regarding implementation and best practice strategies for highly visible Quality System programs.
  • Identifies and corrects division wide quality system weaknesses.
  • Partners with other quality professionals to address recurring issues identified throughout the organization. For example, interacting with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns on an as needed basis. 
  • Interfaces with IDS Leadership Team on Quality System initiatives.
  • Provides and analyzes organizational quality metrics as required to assess the effectiveness of quality system improvements.
  • Ensure the customer complaint investigation, procedures, and activities comply with applicable regulatory requirements and standards 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
  • Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information

KNOWLEDGE AND SKILLS:

  • Demonstrated ability to lead, motivate and accomplish results through experienced direct reports and/or peers.
  • Ability to organize and prioritize assignments providing direction to assigned functional teams.
  • Demonstrates effective written and verbal communication skills across all levels.
  • Ability to speak with clarity and manage conflict resolution in a variety of settings; one-on-one interactions, group meetings, and formal presentations.
  • Ability and skill to effectively manage multiple tasks and lead execution of change management plans.
  • Ability and skill to lead or manage the Quality System function for complex systems, continuous improvement projects and project management techniques.
  • Knowledge and understanding of Complaint Handling and Corrective/Preventative Actions processes.
  • Working knowledge and understanding of the Food and Drug
  • Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO).

EDUCATION AND EXPERIENCE:

  • Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / engineering discipline.
  • A minimum of 2 years’ experience in Quality Management/Quality Systems with a focus on Complaint Handling.
  • Two years of supervisory or management experience is recommended.

#LI-OPS

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.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

NA (United States of America)
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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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com