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The individual will play a crucial role in the organization, handling tasks related to document control, quality assurance, and regulatory compliance within our firm.
Job Responsibility:
Oversee the Document Control System
Handle the collection, filing, and maintenance of product data control specifications and documents
Administer inspection criteria and generate reports using QMS software
Conduct and assist with quality and regulatory training sessions
Manage calibration and verification activities for inspection, manufacturing verification, and product testing tools
Perform configuration control audits
Organize and collect monthly KPI reports
Carry out internal audits and report findings
Oversee the Approved Sample process and support regulatory certification activities
Ensure proper documentation for process changes in the QMS system
Perform manufacturing inspections and reviews
Provide quality support to various departments within the organization
Adhere to all company policies and procedures
Requirements:
4+ years of quality systems experience preferred
A Bachelor’s degree in Operations, Quality Assurance or related field preferred
Proven experience in Auditing, with a focus on identifying areas for improvement and implementing necessary changes
Strong background in Call Center Customer Service, demonstrating excellent communication and problem-solving skills
Demonstrated ability to provide exceptional Customer Service, handling queries and complaints with professionalism and patience
Expertise in Engineering Change Control, ensuring all changes are properly documented and communicated
Solid understanding of Document Control processes, including the creation, review, modification, and management of documents
Proficient in Quality Assurance practices, with a focus on maintaining the highest standards of products and services
Expertise in KPI Reporting, with the ability to track, analyze, and report on key performance indicators
ISO 9001 experience and CAPA experience highly desired
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