Regulatory Affairs/Quality Assurance Engineer

Specific Responsibilities

• Ensure the 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.
• C Conduct risk assessments of medical devices and processes.
• Maintain the effectiveness of 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 risk assessments for medical devices and accessories.
• Development and prototyping of new products with existing or new vendors.

Abilities

• Familiar with FDA CFR 820, ISO 134850, SOPs regulations.
• Extreme attention to details.
• Ability to think outside the box with excellent problem solving abilities.
• Excellent interpersonal, communication, and writing skills.
• Hightly 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.

Requirements

• Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field. (Master degree preferred.)

Benefits

• Medical
• Dental
• Vision
• PTO
• 401K
• Legal Services
• FSA
• Life Insurance

Pay

Salary Range $68,000 - $72,000/Annual