Job Summary:The Quality Engineer provides cross-divisional support for remediation efforts and is responsible for independently establishing and maintaining quality standards across a portfolio that includes medical devices, commodities, OTC drugs, and cosmetic products. The role involves evaluating production processes, recommending improvements, managing suppliers, and ensuring compliance with regulatory requirements through proper documentation and quality systems.
Roles & Responsibilities:- Provide quality expertise in Product Development, Design Control, Design History Files (DHF), CAPA, Risk Management, and CE Technical Files.
- Collaborate with suppliers to resolve quality issues, implement corrective actions (CAPA, SCAR), and lead supplier qualification activities.
- Investigate product and process non-conformances, out-of-specification results, and implement corrective and preventive actions.
- Ensure compliance with domestic and international regulations; review design and quality documentation for adherence to requirements.
- Develop and implement methods for process control, validation, testing, inspection, and continuous improvement.
- Design experiments to identify process variation and apply Statistical Process Control (SPC) techniques.
- Perform product testing and data analysis to monitor quality levels, identify trends, and reduce defects.
- Coordinate testing with internal and external laboratories.
- Create and maintain product documentation such as Device Master Records (DMR) and support regulatory submissions (e.g., 510K, letters to file).
Education & Experience:- Minimum 2 years of experience in Quality or Engineering.
- At least 2 years of industry experience in Medical Devices, Pharmaceuticals (Drugs), or related fields preferred.
- Working knowledge of quality standards and regulations such as 21 CFR 820 and ISO 13485.
- Strong problem-solving and analytical skills using systematic and mathematical approaches.
- Ability to work independently, manage multiple priorities, and escalate issues when needed.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
- Intermediate skills in Microsoft Excel (e.g., formulas, tables, conditional formatting, charting).
