Staff Quality Engineer - CAPA
Job Description Summary
The Staff Quality Engineer serves as CAPA technical investigation expert. Lead and mentor cross-functional teams with root cause analysis using appropriate techniques, conceive solutions and implementation of changes, and devise effectiveness monitoring strategies.
The Staff QE assists in and conduct Corrective and Preventive Action (CAPA) identification, investigation, implementation of a solution, and effectiveness monitoring for product, process and quality system issues.
Monitors CAPA activities for investigations, action item implementation and deliverables
eCAPA software administration (EtQ, TrackWise)
Reporting of CAPA program status, including trending CAPA metrics for actions and solutions.
Document all phases of CAPA activity in compliance with applicable standards, and procedural requirements.
Staff QE maintains CAPA records in a state of audit readiness; critical review of documents.
Guide cross-functional teams assigned to product CAPAs to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished product.
Work effectively with all levels of management to ensure CAPA action plans are supported and that costs/resources needed to implement the plan are available.
Provide training, awareness and promote enthusiasm in the business for CAPA process.
At least a Bachelor’s Degree, Engineering or Science discipline preferred with strong technical aptitude.
Minimum 5 years’ QA experience in medical device industry, with at least a solid understanding of the CAPA process and its potential to drive product quality improvement.
The Staff Quality Engineer should have a proven track record of developing new skills quickly and cross-pollinate the learnings from one area to another.
Ability and willingness to dig deeper, take the ownership of the issue on hand and make a meaningful contribution towards investigation and resolution of the issue.
Excellent organization skills – Must be able to manage a large number of simultaneous projects.
Attention to detail – BD's Staff Quality Engineers must show precision in work, especially as it relates to understanding and documenting complex quality issues.
Excellent writing skills – Must be able to summarize complex issues in a clear, succinct, and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.
Effective interpersonal skills – Work with peers throughout the organization and be effective in engaging resources throughout the organization.
Excellent critical analytical skills – Ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue.
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. #LI-OPS
Primary Work Location
USA CA - San Diego TC Bldg C&D
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Posted 2 months ago
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