Job Description
Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Perform Inspection of incoming materials, components, and subassemblies
• Complete First Article Inspections upon request.
• Perform In-process and finished (sterile and non-sterile, disposable, and durable) product inspection and testing.
• Perform DHR reviews for subassemblies and finished goods.
• Conduct Product Release activities for all conforming products.
• Initiate NCR records for all non-conforming products, components, and subassemblies.
• Quarantine non-conforming product and participate in the investigation process.
• Maintain Inspection area equipment calibration and PM
• Adhere and promote GMP and GDP principles.
• Assist in external/internal audit preparations.
EXPERIENCE/SKILL REQUIREMENTS:
• Organizational skills and attention to detail.
• Firsthand experience using measuring tools such as but no limited to calipers, micrometers, pin gauges and tensile testers.
• Ability to read and understand drawings.
• Experience working with sampling plan.
• Understanding of ISO 13485, CFR21-820, ISO 146444-1, 2 and 3.
• Able to take direction, ownership, and responsibility for QMS related activities.
• Positive and cooperative communication and collaboration with all levels to employees, contractors and vendors.
• Strong understanding of quality control standards and testing techniques.
• Electronic Quality System experience.
• Proficient with Microsoft Office, Excel, and other electronic systems.
• Medical device experience is a plus.
• Experience working a cleanroom is a plus.
EDUCATIONAL REQUIREMENTS:
• High School Diploma, GED, or equivalent with additional training in quality control in medical device industry or similar field.
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