As a Senior Quality Assurance Specialist at Nordberg Medical, you will play a crucial role in ensuring compliance with quality and regulatory requirements for our first product, JULÄINE, an injectable medical class III product, and future products as well. You will work closely with the RA and QA team, as well as with other teams like production, commercial, clinical, and R&D to prepare and submit complying quality requirements and to support product approvals in different regions. In your role, you will report to the Director of Quality Assurance and Regulatory Affairs.Key Responsibilities include:Lead complaints investigation and manage and facilitate the implementation of 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 the 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 that their production satisfies US FDA and EU MDR requirements.Minimum 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.You have a strong team spirit, are curious, and meticulous.Nice to have: experience in Design Process, PSUR reports, and experience with MDSAP.As a Senior Quality Assurance Specialist, you will be part of our remote QA/RA team that works closely together based in several European countries and play a critical role in the success of our company. Our entrepreneurial spirit and teamwork philosophy will enable you to deepen your knowledge and expand your experience to new geographies and new products.We are looking for colleagues who align with our mindset and values: Entrepreneur, Multiculturalism, Flexibility, Trust, Excellence, and Authenticity.Nordberg Medical 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.#J-18808-Ljbffr