Sr. Quality Engineer/Quality Engineer

Position Summary

• Maintain the equipment calibration and preventive maintenance program by tracking existing, new and obsolete equipment as well as ensuring calibrations are current.
• Advance electronic QMS system through setup, validation and maintenance.
• Design control experience required. 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.
• Help with internal and supplier audits to ISO 13485, FDA QSR/QSIT requirements.
• Conduct trend analysis of quality data.
• Support ISO 13485, and FDA QSR activities.
• Review data and resolve issues concerning incoming, in-process, and final inspection and test activities.
• Conduct 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 strongly desired.
• 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.