Job Description

Position Summary:

(Please describe in 2 - 4 sentences, the major duties and responsibilities of this position.)

This position has the responsibility and authority to participating in the development, documentation, maintenance, and improvement of the Corrective Action Preventive Action (CAPA) program and 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 audit response submissions; timely closure of initiated CAPAs associated to internal or external audit findings; Management Reviews and Quality KPI Reporting.

Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):

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

CC 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.
As a CC coordinator, quality engineer shall facilitate efficient and effective processing of CCs
Regularly communicate with Engineering, Quality and manufacturing to implement robust CC within defined timeline.
Track and Trend CC metrics
Coordinate with cross-functional team for root cause analysis and corrective & preventive actions.
Conduct Verification of Effectiveness for the CCs
Drive CC Review Board meetings effectively, to get support from senior management team for CC implementation.

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.

Management Review:

Generate Management Review presentations.  Present metrics to management regarding the performance and effectiveness of the quality system.
Evaluates, makes recommendations and implements improvements to the quality system as part of continuous improvement activities.
Develop weekly Quality Systems Metric Report and share with Senior Quality Management
Develop, Support and tracking of site specific as well as global Key Performance Indicators (KPI)

Quality Engineering Support:

Assists Quality Engineers, Engineering and Operations staff in developing quality plans, inspection work instructions and procedures, equipment operation documents or any other quality systems document
May perform other quality related duties and responsibilities as assigned

Job Specifications:  The minimum education and experience required to perform this job competently.   

Bachelor's degree in engineering or related field with 5 - 7 years related experience and/or training in manufacturing environment; or equivalent combination of education and experience
Knowledge of FDA 21CFR part 820 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 and 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 Certified Quality Engineer
ASQ Certified Quality Auditor
Six Sigma Black Belt Certified
Experience in working in ISO 14644 Class 8 Cleanrooms

Organization Linkages:  List the titles of individuals and organizations with which this position has the most frequent and significant contact.  Briefly describe the nature of those contacts.

Department Staff Member
Site Quality Lead and Senior Site Management
Site Department Managers – support, train, assist in effective and timely Quality System evaluations and implementation activities.
Customers