|
Summary:
|
|
The Quality Assurance (QA) Specialist position is responsible for managing to support data management and analysis activities. The role primarily involves transitioning critical data from PDF documents to structured Excel sheets, followed by thorough analysis using Excel or Minitab to support quality monitoring, process improvement, and compliance initiatives.
|
|
Responsibilities:
|
- Extract and convert quality-related data from PDF documents into Excel spreadsheets with a high degree of accuracy.
- Validate the accuracy and integrity of transcribed data to ensure consistency with original sources.
- Organize, clean, and structure data to facilitate LoTs analysis on quality data and reporting.
- Conduct statistical analysis using Excel or Minitab to identify trends, variances, or anomalies in quality performance.
- Generate and maintain dashboards, charts, and summary reports for internal stakeholders.
- Support root cause analysis and CAPA (Corrective and Preventive Actions) initiatives by providing data insights.
- Collaborate with cross-functional teams including production, engineering, and compliance to ensure data-driven quality decision-making.
- Adhere to documentation standards and maintain data confidentiality and traceability.
- Continuously looking for opportunities to improve data handling and reporting processes.
- Maintain accurate documentation and ensure data confidentiality.
- Participate in training and development programs to build quality and data analysis skills.
|
|
Essential Functions of the Role**:
|
- Time management over multiple time zones
- Must have manual dexterity (use of mouse, keyboard), to type and enter data in the computer as well for
preparing presentations
- Effective communication skills; negotiating, conference calls, video calls, talking, listening
|
|
Work Experience Requirements
|
- Number of Overall Years Necessary: 2-5
Experience in the medical device industry is highly preferred in the areas of data analysis, complaints, CAPA, Quality
|
|
Education Requirements
|
- Bachelor's degree in science, engineering, statistics or related discipline
- Experience with ISO 13485, 21 CFR 820, MDD / MDR, ISO 14971
- Exposure to document automation or PDF data extraction tools (e.g., Adobe Acrobat Pro, Tabula, etc.) is
an advantage
|
|
Specialized Skills/Technical Knowledge:
|
- Strong proficiency in Microsoft Excel (pivot tables, charts, formulas) and working knowledge of Minitab.
- Experience with data extraction and manipulation from PDFs.
- Familiarity with quality tools and statistical techniques.
- Attention to detail and a commitment to data accuracy and quality.
- Strong organizational, communication, and documentation skills.
|
