Job Description:
As a Quality Systems Manager, you will play a key role in ensuring that the quality management system is effective and compliant with regulatory requirements.
Key Responsibilities:
* Manage processes and personnel within the Quality Systems department to ensure compliance with all applicable regulatory and business requirements.
* Establish and maintain quality system requirements in accordance with FDA QSR (21 CFR 820), ISO 13485, MDR, and other applicable regulations.
* Report on the effectiveness of the quality management system and identify areas for improvement.
* Ensure compliance to the MSDAP Program.
* Promote awareness of regulatory requirements and quality management system requirements throughout the organization.
Requirements:
* Excellent working knowledge and proven track record in all aspects of ISO13485 and FDA QSR requirements.
* Regulatory experience/knowledge.
* Good organizational, supervisory, technical writing, and investigation skills are required.
* Excellent communication and interpersonal skills.
* Proven ability to influence.
This is an exciting opportunity to join a team dedicated to delivering high-quality products and services. If you have a passion for quality management and regulatory compliance, we encourage you to apply.