Senior Quality Assurance Specialist
hace 4 días
Job Summary: We are seeking a highly skilled Senior Quality Assurance Specialist to join our remote QA/RA team based in several European countries. As a key member of our team, you will play a critical role in ensuring compliance with quality and regulatory requirements for our medical devices.
Key Responsibilities:
- Lead complaints investigation and manage Corrective and Preventive Actions (CAPA) in collaboration with the CMO and internal stakeholders.
- Work with QA/RA department to develop relevant documentation.
- Support audits from regulatory authorities.
- Assist in developing the company's quality management system, including its compliance with ISO 13485 standards.
- Manage and investigate external product-related complaints.
- Work with CMOs to ensure their production satisfies US FDA and EU MDR requirements.
Requirements:
- Experience with MDR class IIa and/or Class III.
- Experience working with ISO 13485, ISO 14971 is a plus.
- Knowledge and understanding of US FDA requirements.
- Experience managing Change Requests, CAPA.
- Excellent written and verbal skills in English; another language is a plus.
About Us: Nordberg Medical Ab is an equal opportunity employer and is open to remote/hybrid work. You will be required to travel and attend group meetings regularly. You need to have the right to live and work in the EU as we are unable to sponsor work visas.
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