Sr. Engineer II - Quality Engineering
The purpose of the Sr. Engineer II Quality Intelligence is to analyze data of non-conforming events and supply quality issues, to determine the root cause of issues, and to lead teams to design and execute proactive solutions to eliminate and troubleshoot quality related issues.
- Leads and manages investigations to identify root causes, establishes corrective actions and executes prevention plans in products and/or processes (both internal and external)
- Approves and defends corrective actions for deviations, provides formal structured approach to assist in determining root cause for nonconforming events and evaluate CAPAs for lifecycle effectiveness
- Reviews Analytical Methods and Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned
- Assure timely completion of CAPA items
- Proficient in process, product, and data review within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, material and technique-related issues
- Monitor the site specific indicators for CAPAs/Deviations/Complaints/Yield/CPP/CQA as appropriate and escalate potential outliers or negative trends to the appropriate areas as needed
- Works with Quality Organization to collect Voice of Customers and understand non-conforming events
- Works with the Supplier Management Organization to mine, analyze data and drive root cause analysis and corrective actions that will help eliminate supplier related quality issues
- Analyzes data/metrics using sound statistical practices. Develops and implements solutions based on statistical analysis
- CAPA management for the facility, criticality assessment of CAPA's, and CAPA effectiveness
- Checks complaint investigations/evaluations for completeness. Supports the preparation of periodic reporting (daily, weekly, monthly, quarterly, annually).
- Researches and writes special investigations for trends. Reacts quickly to trends and issues detected by quality intelligence data and effectively addresses them.
- Ability to travel domestically and internationally as needed. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelors degree from an accredited institution in an Engineering, Mathematics or Physical Science discipline or equivalent years of directly related experience.
- Minimum of 5 years of Quality Engineering experience or Manufacturing Process Engineering experience within the medical device industry.
- Root cause analysis; data-driven decision making; and strong risk analysis skills. Must have a good understanding of medical device quality regulations and GMP; strong computer skills; excellent written/verbal/communications; strong interpersonal skills; and must be able to perform in a fast-paced, team environment.
- Coursework in Quality Engineering, Statistics, project management, or CQE/ASQ
- Lean Six Sigma preferred
- Ability to travel up to 40% of time
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