Quality Engineer - Spinal Devices

Position Overview

Expanding Innovations is currently seeking a highly skilled and experienced Quality Engineer to join our dynamic team. The ideal candidate will have a minimum of 4 years of hands-on experience in the medical device industry, with a strong background in quality assurance, risk management, and DV&V. This role will play a crucial part in ensuring the highest standards of quality and safety as we develop new and novel spine surgical devices.

Product Quality Assurance:

• Develop inspections and tests to verify product quality at various stages of the manufacturing process.
• Train quality assurance teams on proper implementation of established inspections.
• Collaborate with R&D and manufacturing teams to resolve quality issues and implement corrective actions.

Supplier Quality Management:

• Evaluate and monitor supplier performance, ensuring adherence to quality standards.
• Conduct supplier audits and collaborate on continuous improvement initiatives.

Document Review

• Collaborate with R&D engineering to review project documents to assure high standards and eliminate opportunities for communication issues with vendors.

Quality Management System (QMS):

• Develop, implement, and maintain the QMS to ensure compliance with regulatory requirements and industry standards.
• Conduct internal audits to assess and improve the effectiveness of the QMS.
• Collaborate with cross-functional teams to identify and mitigate product and process risks.
• Implement and maintain risk management processes in accordance with industry best practices.

Regulatory Compliance:

• Stay abreast of relevant regulations and standards (e.g., FDA, ISO) and ensure the company's compliance with these requirements.
• Support regulatory submissions and provide documentation for audits.

• Bachelor's degree in engineering or a related field.
• Minimum of 4 years of experience in a quality role within the medical device industry.
• Strong knowledge of FDA regulations, ISO standards, and other relevant quality requirements.
• Experience with risk management processes and techniques.
• Excellent communication and collaboration skills.
• Detail-oriented and meticulous, with a commitment to delivering high-quality results.