Quality Systems Specialist

Job description

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce. The purpose of the Quality Systems Specialist is to assist the QA & RA Manager in ensuring overall compliance and effectiveness of the quality system. What You’ll Do: - Manage the audit program for internal and external audits. - Support management during third-party audits/inspections (preparation, execution, and responses). - Conduct supplier audits when deemed necessary. - Oversee supplier quality performance. - Ensure QMS documents are robust and in compliance with ISO 13485 and 21 CFR 820. - Provide recommendations for improvements to the overall system and drive continuous improvement. - Drive and evaluate root cause analysis, corrective action plans, and effecti...