DescriptionPOSITION PURPOSE: This position is responsible for assisting Management in ensuring compliance to our ISO 13485 certified Quality Management System and applicable FDA, CE, USDA and International regulations. Key elements of the system that this position will work in and maintain are Internal Audits, Document Control, Corrective Actions and Preventive Actions (CAPAs), Supplier Management, Control of Infrastructure, Training, and assistance with Management Reviews, prepare for ISO certifications and audits.
REPRESENTATIVE DUTIES AND RESPONSIBLITIES:
- Core duties and responsibilities include the following. Other duties may be assigned.
- Maintenance of Biomed Quality Assurance processes by direct integration with purchasing, manufacturing, packaging & fulfillment personnel and processes;
- Ensure the Quality System is and will continue to be ready for ISO/FDA quality system audits.
- Manage the existing relationship with ISO registrar and notified bodies. Coordinate, schedule, plan, and respond to audits conducted by the existing ISO registrar and future FDA audits.
- Schedule, coordinate and conduct internal audits on QMS.
- Collection, organization and analysis of operations and quality system data including CAPA, customer complaints, nonconformance?s, audit outcomes, supplier evaluations, inspections, etc.;
- Write, review, and update Quality System documentation including SOP, instructions, forms, plans, and related documentation. Train and evaluate employees in QMS procedures, controls and systems.
- Maintain CAPA Program: identify and manage CAPA?s, perform root cause analysis on issues, coordinate with other departments to come up with containment actions and solutions to issues;
- Investigating customer complaints and Quality issues, issuing Corrective Actions as necessary and participation of Supplier Audits (as necessary);
- Maintain and document systems improvement through CAPA system reporting;
- Train and evaluate employees in QMS procedures, controls and systems;
- Responsible for ISO documentation control and record maintenance including periodic review and revision of all quality methods, documents, and procedures;
- Manage and maintain our electronic Document Control System;
- Understand, review and continually improve both production quality processes and quality control processes;
- Lead internal quality audits against FDA, cGMP and ISO standards, including scheduling of Internal Audits;
- Oversee organization of maintenance and calibration of laboratory equipment and quality control materials, including integration of infrastructure for use;
- Occasional customer service and technical assistance;
- Integrate Quality requirements in design, development, and manufacturing functions and documentation including process validation (installation, operation, and process qualification);
- Expand the scope of supplier qualification, management processes and capabilities. Visit, conduct, and write reports for supplier quality audits at critical suppliers (moderate travel may be required).
- Maintain the supplier qualification and management processes, possibly including supplier quality audits at critical suppliers;
- Maintain open communication with all departments and upper management.
- Attendance at monthly all employee Safety Meetings
Job RequirementsEducation Required: High School
Experience Required: Entry Level
Last updated on 06/24/2021
20.00 - 25.00
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Personnel Source, Inc. is an equal opportunity employer.