Data analyst
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Under the supervision of the Senior Manager Quality Assurance (QA) and Quality Control (QC), the Quality Control Data Analyst is responsible for identifying key data sources that provide indicators of product quality as well as gathering, modeling, and maintaining the data. The Quality Control Data Analyst performs data tracking and trending and communicates findings using visualizations to applicable groups such as Quality Assurance, Technical Operations, Research and Development and other business leaders as needed. The Quality Control Data Analyst is also required to perform quality control testing for production and/ or investigations. Responsibilities- Identifies data to be tracked to provide an analysis of product performance.
- Creates Statistical Process Control (SPC) charting and other visualizations as needed to track and trend the data.
- Monitors data on a routine basis to identify and evaluate trends and assists in investigations.
- Communicates data findings in timely manner to initiate investigations and actions as needed.
- Performs comparative analyses of product performance data in both manufacturing and in the field in an ongoing effort to mitigate the risk of field failures/ actions.
- Demonstrates understanding of wafer/ sensor and instrument handling, use and maintenance.
- Proficient at operating testing platforms and performing basic troubleshooting as indicated in procedures/ instrument user manuals.
- Works with manufacturing engineering on advanced instrument troubleshooting when quality control technician expertise is needed.
- Performs quality control testing for routine production to meet customer demand and experiments/ investigations as needed. Collaborates with Quality Assurance and Technical Operations to share findings as appropriate.
- Understands and follows all cGMP and cGDP requirements.
- Participates in and contributes to a safe working environment.
- University degree or a combination of education and technical experience
- 2-3 years of industry experience in an ISO 13485 or cGMP medical device manufacturing environment
- Ability to work effectively within a team environment while satisfying individual responsibilities and objectives
- Excellent high level oral and written communications skills
- Demonstrates a willingness to collaborate across teams and job functions and ensures clear communication to support manufacturing
- Ensures compliance while meeting business objectives
- Strong understanding of Statistical Process Control (SPC), control charting etc.
- PC experience including use of statistical tools such as Minitab, PowerBI etc.
- Adaptable and willing to take on new tasks and responsibilities
- Experience working in a GMP/ ISO point of care medical device manufacturing environment
- Additional medical device quality control experience is a plus
- Proficiency with SPC processes and tools a plus
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