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About the Role
Seeking a motivated, intelligent, hard-working individual to grow as part of the Quality Assurance and Regulatory Affairs team.
Responsibilities
- Develop and design effective test methods.
- Facilitate software design and development for medical devices.
- Perform performance testing and reporting on software, hardware, and accessory compatibility.
- Maintain and calibrate the accuracy of all testing equipment.
- Perform risk assessments for medical devices and accessories.
- Maintain the effectiveness of the quality control system and non-conforming materials control system.
- Discuss and solve quality problems with vendors.
- Develop and prototype new products with existing or new vendors.
- Investigate problems and make improvements on current products.
- Engage in new product development.
Requirements
- 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, communication, and writing skills.
- Highly organized.
- Excellent computational skills (MS Office, databases, testing).
- Knowledge of C/C++ is a plus.
Skills
- FDA 21CFR 820
- ISO 13485
- Risk Assessment
- Medical Materials
- Electrical Circuits
- Basic Programming
- Problem Solving
- Interpersonal Skills
- Communication Skills
- Writing Skills
- Organization
- MS Office
- Databases
- Testing
- C/C++
Work Type
- Full-time
Experience Level
- 2-5 years of experience as a quality representative in a FDA or ISO 13485 compliant company
Education Level
- Bachelor degree in mechanical, electrical, material, biomedical engineering, or relative field.
Salary/Compensations
- $65,000 - $70,000 per year
Benefits
- Medical
- Dental
- 401K
- Vacation