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)

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

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