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 Overview

Helios is seeking a dedicated Quality Associate to support our Quality and Quality Control teams. In this role, you will be responsible for maintaining quality system records and documentation to ensure our products meet the highest standards. Key responsibilities include performing inspections and testing of materials and products, conducting batch record reviews, and assisting with validation and equipment calibration. You will ensure compliance with all company quality policies and regulatory requirements for medical devices, including 21 CFR Part 820 and ISO 13485.

Essential Job Functions

Quality System Support: Provide daily on-site support to Quality and Quality Control, aiding in Quality Systems maintenance and ensuring compliance with 21 CFR Part 820 and ISO 13485:2016.

Inspection & Release: Complete inspections and release raw materials for use in manufacturing. Perform in-process testing and review documents to determine material/product disposition.

Batch Record Review: Conduct batch record reviews and releases, including the review of nonconformances.

Documentation Management: Prepare and review procedures and specifications, including Standard Operating Procedures (SOPs), work instructions, and other Quality documents. Assist in maintaining documentation for Complaint Management, Document Management, and CAPA.

Process Monitoring: Monitor production processes to ensure adherence to SOPs. Identify and report non-conforming processes and materials.

Equipment & Validation: Support equipment calibration and preventative maintenance according to defined schedules. Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation testing.

Compliance: Ensure compliance with all company policies relative to the manufacture of product, lot control requirements, and documentation requirements.

Skills and Abilities

- Excellent attention to detail and strong observational skills.

- Basic understanding of quality and quality control principles.

- Proficiency in Google Workspace for documentation and reporting.

- Strong verbal and written communication skills.

- Ability to follow detailed instructions and standard operating procedures (SOPs).

- Ability to work independently and as part of a team.

- Strong organizational and time management skills.

Education & Experience

Education: Bachelor’s degree in Engineering or Science.

Experience: Minimum of 2 years of experience in a regulated industry or equivalent training.

Regulatory Knowledge: Knowledge of medical device quality, including FDA and ISO requirements.

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.

Benefits

- 401(k)

- Dental insurance

- Health insurance

- Paid time off

- Vision insurance

To Apply

Please send your cover letter and CV to careers@helioscardio.com.