
Quality Assurance Specialist Lead
5 days ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at TN Sweden.
The primary objective is to develop and maintain quality processes that ensure compliance with regulations, including Medical Device Regulation (MDR), Quality System Regulation (QSR), and ISO 13485.
Key Responsibilities:
- Design, manage, and review Quality Management System (QMS) processes to guarantee compliance and efficiency.
- Evaluate QMS alignment with medical device regulations, ensuring adherence to industry standards.
- Support CAPA, non-conformance, change management, and audit processes to maintain quality assurance.
- Analyze QMS performance, focusing on key processes and reporting to identify areas for improvement.
- Conduct QA reviews, investigate non-conformances, and manage Corrective Action Preventive Actions (CAPA).
- Serve as an internal auditor, coordinating external audits to ensure seamless operations.
- Examine quality data to pinpoint training needs and implement effective solutions.
- Address Quality Assurance and Regulatory Compliance concerns, driving process improvements.
- Lead projects aimed at enhancing quality assurance processes, fostering a culture of excellence.
- Coordinate and support on-site audits conducted by external providers.
Qualifications & Skills:
- Bachelor's or master's degree in a relevant field, preferably science or engineering.
- Minimum 5 years of working experience in a regulated industry, preferably life sciences.
- Strong knowledge of quality systems and quality assurance principles.
- Prior experience in Med Tech or Pharma industry preferred, with familiarity with applicable regulatory requirements and ISO standards.
- Proven leadership skills, with ability to lead operations with or without personnel responsibility.
- Fluent English language proficiency, both written and spoken.
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