Job Description Summary

The Post Market Senior Quality Engineer will design quality projects, develop the documentation, manage Post Market Quality CAPAs, manage local quality standards, and specify the requirements that a project or CAPA must satisfy. Quality engineers monitor the PMQ process, and are responsible for leading resolution of problems and remediation of internal and external inspection/audit observations.

Job Description

• Responsible for being the primary quality representative for BD MMS Infusion Post Market Quality projects - this includes optimization of post market quality processes for existing and new product development as well as sustaining efforts.
• Responsible for creation, review and/or approval of CAPA documentation in support of CAPA administration.
• Manage all post market quality aspects of the CAPA process: initiation, investigation, planning, implementation, verification of effectiveness and TrackWise administration.
• Provide clarification and guidance to teams on overall quality system with emphasis in process controls. Report status of projects and CAPAs to designated functional leaders according to established frequencies.
• Work closely with project team members to ensure CAPA and project deliverables are met.
• Works together with other Quality Engineers to ensure effective administration of Post Market Quality projects and CAPAs.
• Monitors and ensures compliance with company policies and international standards.
• Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements of Post Market Quality software systems.
• Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation.
• Active participant in the development of project requirements, system hazard analysis and validation reviews.
• Work closely with Software Engineers to ensure effective validation of user needs.
• Ensure that CAPA and project files are complete and auditable.
• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.