Job Opportunity:
* Assist in maintaining and enhancing the Quality Management System to ensure product quality.
* Manage internal processes, interface with contract manufacturers, QA consultants and testing contractors, and handle multiple projects related to product and compliance enhancements.
* Contribute to notified body audits and internal audits, and maintain quality system schedules.
* Support a team ensuring that manufactured products meet requirements.
* Banish quality issues by analyzing root causes and implementing corrective actions.
* Verify incoming materials adhere to specifications.
Requirements:
* Engineering or science degree.
* Quality certification required.
* Minimum 4 years of experience in a medical device QA role within a medical device company.
* Thorough understanding of ISO 13485, EU MDR, and 21 CFR Part 820.
* Lead auditor and/or regulatory certifications desirable.
* Project management experience.
* Excellent problem-solving and communication skills.
About This Role:
* Develop innovative ENT medical devices for outpatient procedures under local anesthesia.