Quality Assurance Engineer - Medical Devices

Our company is seeking an electronics engineer to work in our rapidly growing organization. The successful candidate will be an integral part of our team, and will be required to install and diagnose malfunctioning systems as well as perform preventive maintenance on our laser equipment line. This is a fantastic opportunity for an ambitious applicant interested in becoming an integral part of a growing team.

Responsibilities

• Oversee production of medical lasers and testing, including software.
• Responsible for materials procurement for laser components.
• Establishing relationships with staff, vendors, suppliers, and other professionals in the field.
• Responsible for designing, inspecting, testing, and quality control of components, equipment and products.
• Ensuring all equipment and products meet health and safety regulations.
• Observing existing processes and making recommendations for improvement.
• Developing effective maintenance, testing, and quality control procedures.
• Monitoring processes, systems, and staff, and punctually identifying problems.
• Liaising with engineers, other professionals, as well as clients to ensure quality projects are completed to specifications
• Responsible for yearly FDA inspection for Class II medical device category.
• Oversee FDA 510K registration for existing products.
• Perform additional tasks to be determined by CEO and COO.
• Writing specifications, instructions, reports, and handling other required administrative duties

Required Knowledge, Skills and Abilities

• Experience in software engineering/electronics engineering
• Experience in production, quality control, quality assurance of medical grade laser
• Experience with FDA inspection of facilities for Class II
• Work hours 8:30-5:30 M-F
• Paid Holidays/vacation after 1st year

Job Type: Full-time

Pay: $25.00 - $30.00 per hour

Expected hours: 40 per week

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Work Location: In person