Job description

Seeking a motivated, intelligent, hard-working individual to grow as part of the Quality Assurance and Regulatory Affairs team.

PRIMARY DUTIES AND RESPONSIBILITIES

• Develop/design effective test methods.
• Facilitate software design and development for medical devices.
• Performance testing and reporting on software, hardware, and the compatibility for all accessories.
• Maintain/calibrate the accuracy of all testing equipment.
• Perform risk assessments for medical devices and accessories.
• Maintain the effectiveness of quality control system and non-conforming materials control system.
• Discuss and solve quality problems with vendors.
• Development and prototyping of new products with existing or new vendors.
• Investigate problems and make improvement on current products
• New product development.

REQUIREMENTS

Education : Bachelor degree in mechanical, electrical, material, biomedical engineering, or relative field.

Training : SOPs, Risk Assessment/ On-the-job Training

Abilities :

• Familiar with FDA 21CFR 820 and ISO 13485 regulations
• Knowledge of European regulations is a plus
• Extreme attention to details
• Knowledge of common medical materials (silicone, polyurethane, etc.)
• Knowledge of electrical circuits
• Knowledge of basic programming
• Able to think outside the box with excellent problem solving abilities
• Excellent interpersonal, commutation, and writing skills
• Highly organized
• Excellent computational skills (MS Office, databases, testing)
• Knowledge of C/C++ is a plus.

Experience : 2-5 years of experience as a quality representative in a FDA or ISO 13485 compliant company

Medical

Dental

401K

Vacation

Job Type: Full-time

Pay: $65,000 - $70,000 per year