Job Description
Assist in the maintenance of our Quality Management System (QMS) and ensure product quality across the supply chain.
Key Responsibilities
* Maintain the effectiveness of the QMS and make continuous improvements to it.
* Manage day-to-day QA activities, including frequent interface with contract manufacturers, QA consultants, and testing contractors.
* Responsible for assisting in notified body audits and internal audits.
* Maintain and coordinate quality system schedules, including supplier and internal audits, management review, and documentation updates.
* Support the team to ensure product manufacture and testing meets the requirements.
* Build and maintain strong relationships with suppliers, monitor their performance, and conduct audits to ensure compliance with quality standards.
* Investigate, analyze, and resolve any product quality problems, including root cause analysis and implementing corrective and preventive actions.
Required Skills and Qualifications
The successful candidate will have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. They will also have excellent problem-solving and communication skills, as well as the ability to manage critical projects as part of an interdisciplinary team.
Benefits
This role offers the opportunity to work in a fast-paced environment, contribute to the development of quality systems, and advance your career in the medical device industry.