QA Specialist (IEC 62304 Implementation)

Company Description Pinnacle Compliance Solutions (PCS) is a Netherlands-based leader in compliance management services, specializing in regulatory support for medical device, health, and safety industries. With a focus on tailored solutions, PCS helps businesses meet high standards while navigating complex regulations. Our expert team stays updated on evolving requirements to enable clients to maintain compliance, reduce risks, and drive growth. By aligning compliance strategies with business objectives, PCS delivers efficient and sustainable solutions for organizations in highly regulated sectors. Role Description We are seeking a full-time remote QA Specialist with expertise in IEC 62304 implementation. The role involves ensuring compliance with quality management and regulatory standards, with a particular focus on IEC 62304. Responsibilities include performing quality audits, ensuring adherence to Good Manufacturing Practices (GMP), and implementing and maintaining comprehensive quality assurance and quality management processes. Additionally, the role requires collaboration with cross-functional teams to establish efficient compliance initiatives. Qualifications Strong knowledge in Quality Control, Quality Assurance, and Quality Management to oversee compliance standards and ensure high-quality deliverablesFamiliarity with Good Manufacturing Practices (GMP) and their implementation within regulated industriesExperience in Quality Auditing with the ability to identify and address non-conformitiesStrong understanding of regulatory compliance requirements, particularly related to IEC 62304Excellent problem-solving, communication, and collaboration skillsBachelor's degree in a relevant field such as Quality Management, Regulatory Affairs, or EngineeringPrior experience in medical device or healthcare industries is a plusAbility to work independently and remotely while collaborating effectively with global teams