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.
- Lead the Customer complaint 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.
- 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)
- As needed, quality engineer shall act as an action coordinator and work along with Supplier Quality Engineer to facilitate efficient and effective processing of SCARs
- Bachelor's degree in engineering or related field with 3-5 years related experience and/or training in manufacturing environment; 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
- Knowledge of various quality system methodologies 8D, Lean, 5 Why's, Pareto Analysis, Six Sigma, PFEMA, 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.
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