• Manages the quality engineering functions of development a sustaining projects within a multidisciplinary project team in accordance with company policies and applicable laws.
• Mentor and develop quality organization to ensure their success.
• Responsible for the overall of Internal & External Audit process
• Responsible for the mitigation process of audit findings to ensure implementation of plans accordingly.
• Plans, schedules, delegates, and tracks QE projects and CAPAS accordingly in support of the company’s goals and objectives.
• Supervises daily QA activities such as calibration, NCRs, device history record
• review and sterile product release
• Supports Management Reviews and related activities.
• Monitors and trends quality data to identify potential quality issues.
• Provide subject matter expertise with design of experiments, process validations, statistics, test method validations, measurement system analysis, sterilization validations, new product development, and risk.
• Develop mastery of our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
• Helps assure product quality associated with development product.
• Reviews document changes for impact on specifications, product quality and compliance.
• Support in product transfers  ensuring they meet quality requirements.
• Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
• Continually improve technical processes, ensure reliability and implement inspections that meet Inari quality standards, Oversees the implementation of continuous improvement initiatives to ensure high quality products and processes.
• Assist with improvements with Inari’s quality system
• Performs other related duties as assigned.

Qualifications

• Proven track record of working with applicable regulations and standards, e.g. QSR, ISO 13485
• Bachelor’s degree in Engineering (mechanical, biomedical, or materials preferred)
• Minimum of 7 years of relevant experience with medical devices, 6+ years of managerial experience in a quality engineering role
• Knowledge of sterilization, biocompatibility, transportation, and shelf life standards.
• Good knowledge of Design Controls and Risk Management for medical devices.
• Availability to travel
• Excellent Bilingual, proven interpersonal, verbal and written communication skills.
• Critical thinking skills and good judgment.