Quality Assurance Specialist
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:
- Responsible for managing the equipment calibration and preventive maintenance process
- Coordinate calibration of manufacturing and R&D equipment, including coordination with calibration vendors.
- Maintain accurate and complete equipment calibration tracker and equipment files.
- Perform Inspection of incoming materials, components and subassemblies. Complete First Article Inspections upon request.
- Work with Manufacturing and Project Engineers to develop inspection and test methods and related acceptance criteria.
- Support improvement processes that include nonconformance action.
- Investigate NCR’s with proper material disposition, as needed.
- Perform manufacturing Device History Record (DHR) review including sterile product release of finished goods.
- Adhere to good manufacturing practices and good documentation practices.
- Promote awareness, visibility and communication relative to QMS goals and initiatives.
- Improve, support and maintain processes within the Quality Management System.
- Participate in CAPA’s to better improve company practices and systems.
- Adhere to a culture of continuous improvement and system efficiences.
- Assist in external audit preparation.
Other duties as assigned.
- 3 or more years of experience in a quality specialist or equivalent role.
- Organizational skills and attention to detail.
- Hands-on experience using measuring tools such as but not limited to calipers, micrometers, pin gauges and tensile testers.
- Understanding of ISO 13485 and CFR21-820.
- Understanding of ISO 14644-1, 2 and 3.
- Able to take direction, ownership, and responsibility for QMS related activities.
- Strong understanding of quality control standards and testing techniques.
- Electronic Quality System experience.
- Proficient with Microsoft Office.
- Excellent organizational, verbal, written and presentation skills.
- Positive and cooperative communication and collaboration with all levels of employees, contractors and vendors.
High School Diploma, GED or equivalent with additional training in QMS and/or focused in medical device.
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