Manager, Quality Control
Topcon HealthcareAbout the role
For over 90 years, Topcon’s vision has been to solve societal challenges around the globe. In healthcare, we are developing innovations that improve patients’ health and quality of life.
We empower eye care providers with advanced imaging, diagnostic solutions, and intelligent data technology. Our robotic devices deliver simplicity without compromise, by capturing clear images with the push of a button.
By joining Topcon Healthcare, you become part of a growing, diverse, global team. With office locations throughout North America, whether you are on-site, remote, or hybrid, our culture empowers you to contribute to company and personal success each day. At Topcon Healthcare, you can grow your career, gain new perspectives, and help address society’s most pressing challenges. If you have drive, passion, and a desire to be part of a collaborative team, we want to hear from you.
At Topcon Healthcare, we don’t wait for the future. We invent it. Join us.
Learn more about working with us at topconcareers.com
The Manager, Quality Control is responsible for implementing processes and leading the Quality Control team, ensuring that every incoming material, in-process, and finished devices meets rigorous regulatory and performance standards, and that nonconforming materials are handled appropriately. We are looking for an individual who possesses effective leadership and excellent organizational and communication skills, with a blend of technical knowledge and hands-on experience. This role is critical to maintain product integrity, operational excellence, and compliance with FDA Quality System Regulation, ISO 13485, and medical device requirements, while building a proactive culture of quality throughout operations.
Responsibilities:
General management of the Quality Control department and its activities.
Supervise (and conduct if needed) quality control reviews at established inspection points and verify maintenance of quality control records.
Train and support Quality Control personnel to ensure effective and competent performance of quality functions.
Determine appropriate documentation for inspection points. Assist with the development of receiving inspection procedures and requirements of finished product and components.
Review and approve records for adequate point of inspection operations.
Participate in the review of design, manufacturing, purchasing, and test documentation to ensure conformance to quality control standards. This can include review of drawings, specification sheets, production procedures, testing and inspection standards, vendor inspections and customer contract specifications
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