AVVie is an exciting early-stage medical device company with an innovative, minimally invasive technology for the treatment of mitral valve disease.
If you are interested in joining a young and international start-up active in medical technology in Vienna, please read on.
Tasks
* Take ownership, implement and maintain the quality management system (ISO 13485 & US FDA QSR) in cooperation with external consultants.
* Support the R&D team with all quality-related issues.
* Compile documentation and integrate into the internal QM system.
* Stay current with external and internal quality system standards and requirements (ISO 13485, ISO 14971, and other applicable standards).
* Develop, implement, and maintain the company’s risk management processes.
* Ensure compliance with design control procedures.
* Prepare and monitor employee training on QMS documents.
* Determine training needs and act as a catalyst for change and improvement in performance and quality.
* Assist in coordination and management of all internal, supplier, and external audits.
* Perform routine audits (internal & external) and quality tests.
* Provide support in identifying deficiencies in quality systems, defining and implementing systematic improvements.
* Drive project activities to ensure timely completion of quality-related project milestones.
* Lead the periodic quality review meetings.
* Identify risks and perform trending of complaints, deviations, and audit findings, and identify appropriate corrective and preventative measures.
* Other duties assigned by the direct supervisor.
Requirements
* Degree in Mechanical Engineering, Biomedical Engineering, or related disciplines.
* Minimum of 3 years of related experience (Quality Systems Engineer) within the medical device industry (Class III medical devices).
* Deep practical knowledge of ISO 13485 and ISO 14971 requirements and other ISO standards relevant to AVVie’s development.
* Experience in compliance activities, including but not limited to notified body audits, FDA inspections, and other regulatory agency inspections and audits.
* Ownership of relevant processes, policies, and projects.
* Where applicable and previously defined, act on behalf of the company in communication with competent authorities and notified bodies.
* Be a contact point for other departments for quality-/IMS-related topics.
* Performance evaluation for direct reports.
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