About Helios Group of Companies:

For over 20 years, the Helios Group of Companies has been at the forefront of tissue repair and regeneration, with biomedical devices that have positively impacted hundreds of thousands of patients globally. Our innovative product pipeline continues this legacy, extending to drug delivery and injectable formulations across diverse medical indications.

Position Summary:

Helios is seeking a dedicated and experienced Quality Systems Specialist to join our team. This role is crucial in ensuring our products and processes consistently meet stringent quality standards and regulatory requirements. The Specialist will provide daily support to manufacturing, engineering, and quality operations, and assist the VP Quality in the implementation, maintenance, and improvement of our Quality Management System (QMS), ensuring adherence to all relevant standards and regulations.

Essential Job Functions:

• Support the maintenance of the Quality Management System to ensure compliance with 21 CFR Part 820, ISO 13485, and ISO 14971.
• Manage documentation processes.
• Support internal audits and conduct supplier audits.
• Oversee the employee training program.
• Conduct Device History Record (DHR) review and manage product release.
• Support the complaint management, Corrective and Preventive Action (CAPA), and nonconformance processes.
• Provide Quality support for product development and manufacturing activities.
• Assist with product and process risk management.
• Support post-market surveillance activities.
• Oversee the Equipment and Calibration program.
• Assist Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation testing.

Education & Experience:

• Bachelor’s degree in engineering or science preferred.
• Minimum of 4 years of experience in medical device manufacturing or equivalent training.
• Demonstrated knowledge of medical device quality.
• Experience with FDA Quality System Regulation and ISO 13485.
• Proven experience working under a medical device Quality Management System (QMS).
• Lead Auditor certification is a plus
• Exceptional attention to detail is essential.

Work Authorization Requirements:

• Candidates must be legally authorized to work in the United States without requiring future visa sponsorship (e.g., H-1B, F-1 OPT, etc.) at the time of hire or at any point in the future.
• This role does not offer sponsorship for work authorization.