Easter Seals Jobs

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.

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

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.