Vice President

3 weeks ago


Maple Grove, United States TRICARDIA Full time

VICE PRESIDENT / SNR DIRECTOR, QUALITY


Location

Maple Grove, Minnesota


Company

Growth-stage medical device company that develops novel, minimally invasive therapies for structural heart disease.


Job Summary

The VP / Senior Director of Quality will play a pivotal role in developing and implementing a robust Quality System and Quality Assurance Department. Driving operations compliance with regulatory requirements, ensuring excellence in quality and customer service.


Responsibilities

- Develop and oversee the company's Quality Policy, quality system, and objectives.

- Direct and monitor quality standards, practices, and performance.

- Provide visionary leadership for quality and customer service initiatives.

- Manage internal and external audits to ensure compliance with quality requirements.

- Develop measurements of quality and report on performance to senior management.

- Collaborate with executives and business unit leaders to ensure efficient quality systems.

- Lead a team of experts in quality engineering, documentation, inspection.

- Initiate investigations and corrective actions to maintain customer satisfaction and regulatory compliance.

- Act independently to uphold quality policy and procedures.

- Serve as the central authority for specification review for critical projects.

- Educate and train leadership, staff, and associates on quality improvement initiatives.

- Serve as the Management Representative, overseeing the implementation of our quality system.

- Lead ISO certification efforts and maintain certification.

- Manage the product complaint system and drive timely resolution of issues.

- Analyze performance data and identify opportunities for improvement.

- Determine regulatory reporting requirements for product complaints.


Education, Experience, and Skills

- Bachelor's degree in a technical field or equivalent experience.

- 5-10 years of related professional experience.

- Intimate knowledge of ISO 13485, CE Mark process, MDD, MDR, Health Canada Device Requirements, and FDA requirements.

- Considerable knowledge of class III manufacturing processes.

- Ability to thrive in a fast-paced, team-oriented environment.

- Strong leadership and project management skills.

- Detail-oriented with excellent communication and problem-solving abilities.

- Knowledge of relevant federal and state laws and regulations.


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