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.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Medical Equipment Manufacturing
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