Quality Manager

About Us:

Medivis is a leader in augmented reality for surgery. Founded by surgeons and radiologists, Medivis is using technological advancements in AR and computer vision to create a holographic future for surgery. We are seeking a dedicated and experienced Quality Manager to join our team and ensure that our products meet the highest standards of quality, safety, and compliance with federal and international regulations.

Position Overview:

As a Quality Manager at Medivis, you will play a pivotal role in maintaining and enhancing the quality management system, ensuring the highest level of product quality and regulatory compliance. You will work closely with cross-functional teams to drive continuous improvement, manage quality-related processes, and uphold the company's commitment to excellence.

Key Responsibilities:

Quality System Management: Oversee and enhance the company's Quality Management System (QMS) to ensure compliance with relevant federal and international regulations, such as ISO 13485 and FDA QSR.

Regulatory Compliance: Stay abreast of evolving quality standards and regulations in the medical device industry, providing guidance to ensure compliance and spearheading necessary updates to quality documentation and processes.

Leadership: Lead and mentor a team of quality professionals, providing guidance, coaching, and fostering a culture of quality and compliance excellence.

Quality Improvement: Collaborate with cross-functional teams to drive continuous improvement initiatives, including the identification and resolution of quality issues, root cause analysis, and implementation of corrective and preventive actions (CAPA).

Audits and Inspections: Coordinate and manage internal and external audits and inspections, ensuring readiness and prompt responses to any findings.

Supplier Quality: Oversee supplier quality management, including qualification, audits, and ongoing performance monitoring, to ensure the quality of incoming materials and components.

Documentation and Reporting: Maintain comprehensive quality records, documentation, and reporting in compliance with regulatory requirements.

Risk Management: Implement and manage risk management processes, ensuring the proactive identification and mitigation of product and process risks.

To apply, please send a CV and a short statement explaining your candidacy to amy@medivis.com

Qualifications:

·     Bachelor's degree in a relevant field.

·     A minimum of 7-15 years of experience in quality management within the medical device industry.

·     Comprehensive knowledge of quality management systems, including ISO 13485 and FDA Quality System Regulation (QSR).

·     Demonstrated experience in managing teams and driving continuous improvement.

·     Expertise in regulatory compliance and experience with audits and inspections.

·     Strong problem-solving and root cause analysis skills.

·     Excellent communication and interpersonal skills.

Benefits:

·     Competitive salary.

·     Comprehensive health, dental, and vision insurance.

·     401(k) retirement plan.

·     Professional development and training opportunities.

·     Unlimited PTO.

·     A supportive and collaborative work environment.

Medivis, Inc. is an equal opportunity employer and welcomes candidates from diverse backgrounds to apply.