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Vice President - Maple Grove, United States - TRICARDIA
1 week ago
Description
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.
