Job Summary

CAPA Engineer

  • Location:
    Winston Salem, North Carolina
  • Job reference:
    US_EN_3_105992_327102
  • Category:
    Project
  • Contract Type:
    Direct Hire

A CAPA Engineer Direct Hire job in Winston-Salem, NC is available through Modis. Our client, who is one of the best-known and most respected names in the medical devices and supplies industry, is seeking an experiencedCAPA Engineer will be responsible developing, implementing and reviewing quality engineering activities, including verification and validation, complaint investigations, quality system investigations and product quality issues.

CAPA Engineer job responsibilities include:

Implement product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
Represent CAPAs during audits and CAPA Review Board meetings.
Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.

REQUIRED QUALIFICATIONS & EXPERIENCE:

Strong Project Management skills, including ability to project manage all CAPA activities.
Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.

If you are interested in this CAPA Engineer job in Winston-Salem, NC then please click APPLY NOW. For other opportunities available at Modis go to www.modis.com. If you have questions about the position or would like more information, please contact Megha Kumar by email at megha.kumar@modis.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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