Medical Device Quality Manager

1 week ago


Upper Burrell Township, United States Xodus Medical Full time
About the Role
Xodus Medical is a dynamic medical device manufacturer committed to advancing patient safety in the Operating Room. We are seeking a seasoned Regulatory Compliance Specialist to join our quality department. As a key contributor to our team, you will play a critical role in ensuring the highest standards of quality and regulatory compliance.

Key Responsibilities
• Develop and implement policies and procedures to ensure compliance with FDA 21 CFR Part 820 and ISO 13485 regulations.
• Collaborate with cross-functional teams to identify and address areas for improvement in our Quality Management System (QMS).
• Conduct thorough investigations into nonconformities related to products, processes, or the QMS.
• Develop and maintain accurate and up-to-date documentation, including procedures, work instructions, and training materials.
• Ensure successful participation in internal audits and external audits from regulatory bodies such as the FDA and CE.

Requirements
• Bachelor's degree in a relevant field, such as engineering, science, or quality assurance.
• Minimum 3 years of experience in a regulated medical device setting with knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Strong analytical and problem-solving skills, with excellent communication and interpersonal skills.
• Ability to work in a fast-paced environment with multiple priorities.
• Salary: $70,000 - $100,000 per year, depending on experience.

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