Senior 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)

• 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

• dExperience supporting the integration of products, systems, or acquired businesses
• .Experience supporting QMS integration in a global environment
• .German language proficiency, written and verbal