Position
We’re seeking a versatile individual for an entry-level Quality and Operations Associate position. In this role, you’ll be responsible for developing and maintaining our Quality Management System, handling tasks such as Software QA, Equipment Management, Supply Chain, QMS Activities, Post-Market Surveillance, and Compliance, reporting to the Quality & Regulatory Manager. Additionally, you’ll work closely with the CEO and Operations Manager on daily business management, including market research, reporting, invoicing, HR, scheduling, and office management.
Responsibilities
- Collaborate with the quality manager to oversee software QA activities and maintain up-to-date documentation.
- Manage incoming products, equipment, and components, ensuring proper handling and compliance.
- Assist in supplier and component qualification, inventory management, and end-of-life component handling.
- Work with the quality manager to maintain and improve the Quality Management System (QMS).
- Manage complaint handling, investigations, and reporting to authorities.
- Conduct market research for new market exploration and/or new product development.
- Assist in report writing, presentations, and invoice handling for contract manufacturers.
- Support operational activities, such as scheduling, office management, and human resources.
Skills
- Knowledge of FDA 21 CFR 820, ISO 13485, and other relevant regulations is a plus.
- Experience in quality assurance is a plus.
- Understanding of programming basics is a plus.
- Strong attention to detail.
- Ability to work under pressure and with minimal supervision.
- Excellent written and verbal communication skills.
- Strong problem-solving abilities.
- Team-oriented mindset.
About you
Minimum bachelor’s degree.