Quality Systems Engineer-CAPA

Summary

 This position has the responsibility and authority to participating in the development, documentation, maintenance, and improvement of the Corrective Action Preventive Action (CAPA) program, Customer Complaint (CC) Program . The incumbent will be responsible for ensuring continued compliance to associated regulations, standards and corporate policies. In addition, provide support to the internal and external auditing programs. Support elements will include hosting, audit response submissions; timely closure of initiated CAPAs associated to internal or external audit findings; and Quality KPI Reporting.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• CAPA Program:  Lead the CAPA process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485, ISO 14971 & FDA 21 CFR part 820), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirements.  As a CAPA coordinator, quality engineer shall facilitate efficient and effective processing of CAPAs and audit non-conformances.  Regularly communicate with Engineering, Quality, and manufacturing to implement robust CAPA within defined timeline.  Track and Trend CAPA metrics, generate weekly CAPA JOS slides.  Coordinate with cross-functional team for root cause analysis and corrective & preventive actions.  Conduct Verification of Effectiveness for the CAPAs  Drive CAPA Review Board meetings effectively, to get support from senior management team for CAPA implementation.  Audit quality systems for deficiency identification and correction  Evaluate, makes recommendations, and implements improvements to the quality system as part of continual improvement activities.
  
  

Customer Complaint Program:  Lead the CC process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485, ISO 14971 & FDA 21 CFR part 820), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirements.  Manage the day-to-day activities of the Quality Systems Customer Complaint team.  Provide guidance to the CC SMEs to ensure complaints are implemented within the defined timelines.  Conduct Verification of Effectiveness for the CCs as needed.  Drive CC Review Board meetings effectively, to get support from senior management team for CC implementation.  Evaluate & make recommendations and implement improvements to the CC program to ensure continuous improvement.  Act as the final app

Audit Support:  Assists with internal audits, external audits and FDA inspections.  Participates in Second/Third party audits and provides input to Jabil response to any findings.  Initiates ACA (audit corrective actions) for non-conformances and follows up for closure.  Facilitate audit non-conformances evaluation and response team meetings.  Manages the “Review Room” (part of the backroom) during all audits.

Management review process support as needed

Minimum Requirements

Bachelor's degree required and five years related experience; or equivalent combination of education and experience.

Knowledge of FDA and ISO standards (13485,14971) for Medical Devices  Ability to multi-task, perform efficiently, and independently  Proficient in Microsoft office products with a basic understanding of statistics may be helpful  Understanding of project management (experience preferred)  Knowledge of various quality system methodologies 8D, Lean, 5 Why's, Pareto Analysis, Six Sigma, 8-D, DFMEA, PFEMA, PPAP, etc. preferred  Strong problem solving skills  Strong organizational skills  Must have strong verbal and written communication skills, work well with diverse groups of people and be able to function independently of direct supervision  Must have good written and oral communication skills  Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.

Preferred Skills: ASQ CQE cert, Lean sixsigma cert, Experience working in ISO 14644class 8 cleanroom

, BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.