What are the responsibilities and job description for the Quality Assurance Manager position at Cytophil, Inc.?
Primary Function:
• Responsible for managing, implementing, and maintaining Cytophil's quality system, and interpreting and enforcing standards requirements to assure compliance.
• Responsible for assessing, interpreting, and applying ISO standards, as they apply, to business practices, products, and owned processes.
• Complete ongoing training and inform Executive Management and the Cytophil management team of quality requirements and emerging ISO standards/requirements which may impact quality system compliance.
• Reports to Chief Executive Officer /President.
Principal Responsibilities:
• Quality Control Process Owner
• Document Control Process Owner
• Management Representative
• Job functions as defined in GP 02-002 (Corporate Organization)
Additional Responsibilities:
• Ensure the conformity of devices in accordance with the quality management system under which the devices are manufactured prior to release.
• Lead cross functional teams to execute quality system projects and obligations.
• Coordinate customer, supplier, and internal audits.
• Manage complaint handling, document control, vendor approval, environmental monitoring, equipment calibration systems, and others where established as the process owner.
• As required, engage with consultants/ services to resolve technical and quality system issues.
• Define and implement quality system processes, procedures, methods, and specifications related to owned processes.
• Support quality system compliance through NCR, Deviation, and CAPA as related to owned processes.
• Oversee, manage, and direct quality personnel to ensure product, quality system, and internal and external stakeholder's requirements are met.
• General authorities as defined within GP 02-002 (Corporate Organization).
Qualifications:
• Acceptable: Bachelor's degree from an accredited university in law, medicine, pharmacy, engineering, chemistry, biology, or another relevant scientific discipline and at least one (1) year of professional experience in regulatory affairs or in quality management systems related to medical devices.
• Preferred: Bachelor's degree from an accredited university in law, medicine, pharmacy, engineering, chemistry, biology, or another relevant scientific discipline and at least four (4) years of professional experience in regulatory affairs or in quality management systems related to medical devices.
Salary : $90,000 - $110,000