Quality Engineer PM Consultant (Data Analytics and reporting)
Carlsbad, CA
7 months contract to start with
Experience: Minimum 15 years professional experience in the applicable role.
Education: Education: Bachelor's /Master's degree in Engineering. Expert and technical lead with proven experience. Focus on Data Analytics and report trending.
The successful candidate will:
• Summarize data from multiple systems (complaints history, products instructions, risk management, etc.) and prepare reports and analysis.
• Work with cross functional groups such as New Product Development, Production, Post Market Surveillance and Sustaining Engineering to ensure Quality problems have been identified and contained.
• Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data.
• Evaluation of complaint information received from clinical environments, such as device failure mode, manufacturing documentation review, labeling and instructions for use review.
• Follow up on Implementation of corrective and preventive actions.
• Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use.
Use problem solving tools and sound statistical analysis to find root causes of product and process issues to meet regulatory requirements and process improvement goals.
Effectively apply quality engineering knowledge and project management expertise to support initiatives and solve business problems.
Tracks and reports weekly during project reviews on status, successes, issues and slippage
Required skills:
* Data Analysis
* MS Excel
* Data Mining
Skillsets highly sought, but not required:
* Tableau
* Python or R
Thanks and Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct: 510-402-4704
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com
linkedin.com/in/imranshikalgar