Key Skills

Job Description

QA/RA Manager at SkylineDx Your job in a nutshell As a QA/RA Manager, you will promote awareness throughout the company of the quality management system, including regulatory requirements, in support of the company goals. You will assure compliance with regulatory and quality standards of the products and services of SkylineDx, contribute to discussions with senior management about the strategy of the company, ensuring QA/RA-aspects are taken into account. You will lead the QA/RA team in maintaining and updating the quality management system. Together we ensure the validation and implementation of clinically relevant scientific discoveries into reliable medical diagnostic assays for diagnosis, prognosis and drug effectiveness prediction that will ultimately contribute to improved patient care. You will work from our Rotterdam office (hybrid work model) and report to the QA/RA Director. Essential Duties and Responsibilities • Translate company strategy into a clear QA/RA roadmap, priorities, and team objectives. • Lead and manage the QA/RA team, ensuring effective execution of quality and regulatory activities. • Hold overall responsibility for the Quality Management System, including change control, document control, non-conformances, audits, risk management, and continuous improvement. • Serve as subject matter expert on IVDR, ISO 13485, and other applicable quality and regulatory standards. • Oversee the preparation, review, approval, and implementation of quality procedures, technical documentation, and validation documentation. • Act as the primary liaison with regulatory authorities for IVD compliance, inspections, and regulatory submissions. • Plan and oversee internal and supplier audits and ensure appropriate follow-up. • Coordinate and deliver quality and regulatory training across the organization. • Ensure products meet applicable quality and regulatory requirements prior to market release. You have • a Master’s degree in life science or business-related topics. • 5+ years of QA/RA experience within the medical device or IVD industry. • strong knowledge of EU IVDR (2017/746) and ISO 13485 requirements. • hands-on experience with Quality Management Systems, including document control, audits, non-conformances, CAPA, and change control. • experience preparing, reviewing, and approving quality, design & development, and technical documentation. • proven experience coordinating quality/regulatory projects and managing timelines. • experience interacting with Health Authorities and Notified Bodies. • team management experience (pre). • knowledge of FDA requirements and guidance for IVD product development (pre). • experience evaluating laboratory test results (pre). • knowledge of ISO 15189 and medical laboratory requirements (pre). • a hands-on mentality and result oriented attitude. • the ability to Influence at all levels of the organization. • strong communication, supervision, and delegation skills. • an excellent command in written and spoken English. We offer • a full-time position, a market competitive salary and market competitive secondary conditions of employment. • a hybrid work model. • opportunities for personal growth. • the best of two worlds: a career in life sciences at an innovative biotech company with the emphasis on clinical diagnostics in close collaboration with an academic environment. • the ability to serve society with science-based solutions. At SkylineDx We live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission, and when needed our passionate side surfaces to clear the way so we can serve society with science-based solutions. Do apply! Send your resume and motivation letter to [email protected]. We refer you to our privacy policy on our website for details about the processing of your personal data. At SkylineDx, we are committed to creating an inclusive workplace where everyone is treated with respect and given equal opportunities. We welcome applications from all qualified candidates, regardless of gender, age, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other characteristic protected by applicable law.

Core Responsibilities

The QA/RA Manager is responsible for leading the QA/RA team and maintaining the Quality Management System to ensure compliance with regulatory standards. They act as the primary liaison with regulatory authorities and oversee the implementation of quality procedures for medical diagnostic assays.

Requirements

Candidates must have a Master's degree in life science or business and over 5 years of QA/RA experience in the medical device or IVD industry. Strong expertise in EU IVDR and ISO 13485 is required, along with proven experience in team management and interacting with Notified Bodies.

Benefits

• Market competitive salary
• Market competitive secondary conditions of employment
• Hybrid work model
• Opportunities for personal growth