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About the Role
Develop and maintain quality and regulatory compliance in Genadynes' processes, ensuring adherence to ISO 13485 and MDSAP requirements.
Responsibilities
- Ensure quality and processes are practiced and maintained.
- Compile documents required for audits.
- Create and maintain product technical files.
- Initiate corrective and preventive actions for non-conformities.
- Maintain/calibrate the accuracy of all testing equipment.
- Conduct risk assessments of medical devices and processes.
- Maintain the effectiveness of the quality control system and non-conforming materials control system.
- Discuss and solve quality problems with vendors.
- Investigate problems and make improvements on current processes.
- Develop/design effective test methods.
- Facilitate software design and development for medical devices.
- Perform performance testing and reporting on software, hardware, and accessory compatibility.
- Perform risk assessments for medical devices and accessories.
- Develop and prototype new products with existing or new vendors.
Requirements
- Familiar with FDA CFR 820, ISO 13485, SOPs regulations.
- Extreme attention to details.
- Ability to think outside the box with excellent problem-solving abilities.
- Excellent interpersonal, communication, and writing skills.
- Highly organized.
- Excellent computational skills.
- Knowledge of European regulations is a plus.
- Knowledge of common medical materials (silicone, polyurethane, etc.).
- Knowledge of electrical circuits and basic programming.
- Knowledge of C/C++ is a plus.
- Maintain MDD/MDR EN ISO.
Skills
- Regulatory compliance
- Quality management
- Cross-functional team management
- Quality assurance
Education Level
- Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field.
- Master degree preferred.
Salary/Compensations
- $68,000 - $72,000/Annual
Benefits
- Medical, Dental, Vision, PTO, 401K, Legal Services, FSA, Life Insurance