🔥 We challenge you!
We are seeking for an enthusiast Quality Assurance Officer to strengthen our team. The ideal candidate will have a background in implementation of ISO13485 requirements, IVDR certification, and/or medical product development. The successful candidate will have a passion for innovation and the ambition to deliver high-
quality solutions for the next generation of medical technology.
👉🏼 You are
• Establish and maintain the company's Quality Management System (QMS) in alignment with ISO 13485.
• Develop and maintain Standard Operating Procedures (SOPs) to guide quality and regulatory processes.
• Conduct internal audits and assessments to ensure adherence to QMS processes, identify improvement areas and implement corrective actions.
• Interpret and apply In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 European regulations and standards for IVDR medical devices.
• Collaborate with product development teams to ensure compliance with regulatory requirements throughout the product lifecycle.
• Prepare and submit regulatory documentation, including technical files, design dossiers, and labelling content, for CE marking and regulatory approvals.
• Lead the development and implementation of risk management strategies and processes for IVDR devices, including risk assessment and mitigation plans.
• Manage and control regulatory and quality documentation, ensuring version control, accessibility, and compliance with regulatory requirements.
• Collaborate with R&D, manufacturing, and clinical teams to provide regulatory and quality input at all product development and commercialization stages.
• Train employees on quality and regulatory processes, ensuring a company-wide understanding of compliance requirements.
💻 Requirements
• Profound knowledge of European regulations IVDR (EU) 2017/746.
•Experience with establishing and maintaining QMS according to ISO 13485
•Prior experience in a startup or fast-paced R&D environment is a plus.
🏦 What do you get in return?
• Expert knowledge on QA methods and tools, medical devices, and testing practices
• Proven ability to carry out system audits to the above standards
• Experience with medical device prototyping, testing, and analysis is a plus
• Innovative problem-solving skills and attention to detail
• Ability to communicate comprehensively and unambiguously procedures and reports
• Motivated team player with good written and verbal communication skills
We offer a competitive salary, and opportunities for career growth within our company. If you are passionate about making a difference in the healthcare and diagnostics, and have the skills and experience we are looking for, please apply by sending your resume/CV, and a short motivation letter to info@soundcell.nl.
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