About Expanding Innovations: Expanding Innovations, Inc. (EI), is an emerging technology leader in the expandable interbody cage sector of the Spine Industry. EI is committed to facilitating better patient care by solving the most challenging clinical problems faced by today’s spine surgeons. As part of our growth strategy, we are seeking a highly motivated & skilled Quality Engineer to join our dynamic team.
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 compliance. 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.
Responsibilities:
Product Quality Assurance:
- Develop inspections and validation 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.
Risk Management:
- 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.
Qualifications:
- 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.
- Experience planning and implementing instrument/implant validations to support NPD activities.
- Excellent communication and collaboration skills.
- Detail-oriented and meticulous, with a commitment to delivering high-quality results.
