Quality Engineer Regulated / Medical Devices

Responsibilities :

• Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR's, global import / export regulations, etc.
• New product setup and management of related projects.
• ssist with Supplier audits, as needed Collaborates with USDA on regulatory compliance activities including regulatory approvals, import / export compliance, traceability, quarantine, safety testing and affidavits.
• Serve as a resource for customer's regulatory and technical inquiries Ongoing maintenance of ISO 13485 based quality system.
• Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution.
• Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
• Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.
• Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
• Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.
• ssists in representing in customer quality audits, supplier quality audits and regulatory inspections.
• Performs investigations and analysis activities to support resolution of quality issues.
• Collaborates with organizational teams to support quality system implementation.
• Creation of new product master files satisfying customer and quality system requirements.
• Ensures quality standards by following company & departmental policies & procedures including, but not limited to.
• Product performance & quality verification.
• Identifying, recording, and investigating problems related to product, process & quality systems.
• Evaluating processes for improvements and standardization.
• Initiating action to prevent non-conformance in products, process, and quality systems.
• Training on quality systems and applicable regulations as identified by supervisor and required by position.
• Tracking / trending aspects of the QMS.
• Other job duties as required.

Requirements :