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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Permobil. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices.
Key Responsibilities- Develop, manage, and review Quality Management System (QMS) processes to ensure compliance with medical device regulations (MDR, ISO13485, FDA).
- Support the management of CAPA, non-conformance, change management, and audits to maintain a high level of quality and compliance.
- Review QMS efficiency, focusing on key processes and reporting to identify areas for improvement.
- Conduct QA reviews, investigate non-conformance, and manage CAPA to ensure timely resolution of quality issues.
- Serve as an internal auditor and coordinate external audits to ensure compliance with regulatory requirements.
- Analyze quality data and identify training needs to improve quality assurance processes.
- Address Quality Assurance and Regulatory Compliance issues to ensure compliance with regulatory requirements.
- Initiate and/or lead projects to improve quality assurance processes and ensure compliance with regulatory requirements.
- Master's or bachelor's degree in a relevant field, such as science or engineering.
- 5 years of working experience in a quality assurance or regulatory compliance role.
- Good knowledge of quality systems and quality assurance within regulated industries (preferably life-science).
- Preferred previous experience from Med Tech or Pharma industry (knowledge of applicable regulatory requirements and ISO).
- Capability in being a manager, leading operations with or without personnel responsibility.
- Fluent in oral and written English.
- Strong computer skills including Microsoft Office.
Permobil is a global leader in advanced rehabilitation technology, passionate about better understanding our users' needs and improving their quality of life through state-of-the-art healthcare solutions. We are committed to creating advanced assistive solutions that make a difference in the lives of adults and children living with disabilities.
We are a sustainable and responsible business committed to continuous improvement, and our customers can trust us to provide market-leading solutions driven by insights-based clinical data.
