Quality Engineer/Sr Engineer
This is a medical diagnostics company developing innovative point-of-care solutions in infectious disease for patients and their medical care providers. We are building a world-class molecular diagnostics platform that leverages our proprietary technologies to enable rapid, sample-to-answer diagnostic testing across a wide range of healthcare environments. We are taking on some of the greatest challenges in healthcare and working to improve the access and quality of care for patients across the globe.
- Maintain the equipment calibration and preventive maintenance program by tracking existing, new and obsolete equipment as well as ensuring calibrations are current.
- Establish and maintain Design History Files.
- Work with R&D and Operations to establish measurable Quality Standards in Manufacturing.
- Advance electronic QMS system through setup, validation and maintenance.
- Identify and connect Business processes’ to QMS standards through process mapping and other tools.
- Trend analysis of quality data.
- Help with internal and supplier audits to ISO 13485, FDA QSR/QSIT requirements.
- Support ISO 13485, and FDA QSR activities.
- Review data and resolve issues concerning incoming, in-process, and final inspection and test activities.
- Failure investigation of in-house nonconforming materials and products
- Other duties as assigned.
Qualifications & Experience
- Bachelors Degree in Sciences/Engineering or equivalent. ASQ CQE/CQA certification preferred.
- 5-8 years experience in Quality Assurance/Engineering field with emphasis on medical devices. IVD experience preferred.
- Thorough knowledge of QSR/QSIT, and ISO 13485.
- Experience with failure investigations and failure report writing, inspection, calibration, trend analysis, and supplier/internal auditing.
- Experience with Microsoft Word, Excel, and Flow-Charting.
- Excellent written and oral communication skills.
- High level of attention to details, capable of efficient use of time, experience conducting part inspections.