Medical Device Quality Manager
Vor 2 Tagen
ONWARD (GTX Medical) invites applications from skilled professionals for the role of Quality Complaint Specialist. As a key member of our team, you will play a vital role in ensuring the quality and safety of our medical devices.
Your primary responsibility will be to handle product complaints, which will involve investigating root causes, analyzing data, and implementing corrective actions in collaboration with cross-functional teams.
This role also requires strong analytical and problem-solving skills, with the ability to gather and analyze data to drive quality improvements and support post-market surveillance activities.
You will work closely with our regulatory team to ensure timely and accurate reporting of serious incidents and assist with early product surveillance investigations.
A bachelor's degree in life sciences, engineering, or a related field is required, along with at least 2 years of experience in the field of medical devices and a thorough understanding of ISO quality management standards, EU MDR, and FDA regulations.
Desirable qualifications include experience with quality management software and statistical analysis tools, as well as proficiency in languages other than English.
The ideal candidate will be a detail-oriented, organized individual with excellent communication and interpersonal skills, able to work effectively in a fast-paced, international environment.
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