Quality Systems Manager
3 weeks ago
At AirLife, we are dedicated to delivering exceptional quality and excellence in every aspect of our business. As a key member of our team, you will play a vital role in ensuring the effective management of our global electronic Quality Management System (Grand Avenue). This position will be responsible for leading the development, implementation, and continuous improvement of Document Management processes across all AirLife entities and business acquisitions.
Key Responsibilities:
- Lead the development and implementation of Document Management processes to ensure compliance with FDA regulations, ISO, and other regulatory standards.
- Manage and administer the electronic Quality Management System (Grand Avenue) across sites and acquisitions to ensure effective quality oversight.
- Provide leadership and guidance to the Document Control team, ensuring the successful implementation of quality systems and processes.
- Collaborate with cross-functional teams to drive continuous improvement and process optimization.
- Ensure the accuracy and completeness of quality management system documentation, ensuring it is inspection-ready at all times.
Requirements:
- 5+ years of leadership experience in a regulated environment.
- 5+ years of experience in a documentation-related position, with a strong understanding of medical device regulations and standards.
- Intermediate to advanced working knowledge of ISO 13485:2016 and FDA QSR.
- Strong leadership and communication skills, with the ability to prioritize and organize a busy workload.
- Ability to work effectively in a fast-paced, dynamic environment, with a focus on achieving quality and regulatory compliance.
What We Offer:
- A dynamic and supportive work environment, with opportunities for growth and development.
- A competitive salary and benefits package, including health insurance, retirement savings, and paid time off.
- The chance to work with a talented and dedicated team, passionate about delivering exceptional quality and excellence.
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