Our client, an early-stage medical device technology company, is seeking a Quality Manager to support its development and manufacturing activities.
Role and Responsibilities
* Maintain the company's Quality Management System (QMS) and report on its performance to senior management.
* Supervise Quality Technicians and Quality Engineers in completing departmental activities and objectives.
* Oversight of quality system aspects, including management reviews, quality reviews, internal audits, and supplier control.
* Manufacturing validation, customer complaints, CAPA/NCR management, and lot release processes.
* Lead the company through external audits and provide QA support to Operations.
Requirements
* Bachelor's degree in a scientific discipline.
* 4 years of experience in the medical device or pharmaceutical industry.
* Strong analytical, writing, and interpersonal skills.
* Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
* Ability to work as part of a team and meet targets efficiently.
This role requires strong organizational, management, and communication skills, as well as good interpersonal and communication skills. The ideal candidate will have a solid understanding of quality principles and their application in development and manufacturing environments.