Quality Systems Specialist

Responsibilities sSupport Quality Management System (QMS) integration activities by leading and owning the Change Control process within a regulated medical device environment .Own and manage the Change Control process to ensure compliance, consistency, and effectiveness .Review and approve change records for completeness, accuracy, and appropriate impact assessments .Ensure changes are implemented appropriately, including verification of downstream activities such as documentation updates, training completion, and record retention .Drive process improvements and standardization to support integration efforts .Evaluate process gaps and define compliant, scalable solutions .Collaborate with cross-functional teams to align change activities with integration timelines and business needs .Mentor and guide change owners and stakeholders on proper change control processes .Provide coaching on impact assessment, documentation expectations, and process requirements .Promote consistent and high-quality execution of change activities across the organization .Develop and revise quality system documentation, including procedures, work instructions, and change records .Ensure documentation is clear, accurate, and compliant with internal and regulatory requirements .Partner with Quality, Regulatory, R&D, and Operations teams to ensure alignment on changes and integration efforts .Act as a quality representative in project discussions and integration activities .Communicate progress, risks, and recommendations to key stakeholders .Work flexibly to accommodate collaboration with teams operating in German time zones (CET/CEST) Qualification sBachelor’s degree in Engineering, Science, or a related field .Minimum of 5 years of experience in a regulated environment, preferably within the medical device industry .Proven experience with Change Control processes and quality system integration or harmonization .Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements, including FDA, ISO 13485, and EU MDR .Deep understanding of interactions between Change Control, Document Control, Training, and Records processes .Excellent technical writing and documentation skills .Ability to work flexible hours to accommodate German time zones Preferre dExperience supporting the integration of products, systems, or acquired businesses .Experience supporting QMS integration in a global environment .German language proficiency, written and verbal #J-18808-Ljbffr