Quality Systems Specialist

Quality Systems Specialist

Required Education: Bachelor's degree in engineering, Science, or a related field

Required Experience/Skills:

• 5+ years of experience in a regulated environment (medical device preferred)
• Proven experience with Change Control processes and quality system integration or harmonization
• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements (e.g., FDA, ISO 13485, EU MDR)
• Deep understanding of interactions between Change Control, Document Control, Training, and Records processes
• Excellent technical writing and documentation skills
• Strong organizational, problem-solving, and project coordination abilities
• Ability to influence, mentor, and drive consistent process execution across cross-functional teams
• Ability to manage multiple priorities in a fast-paced, integration-focused environment
• Strong attention to detail and commitment to quality and compliance
• Collaborative mindset with a proactive, solution-oriented approach
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Teams, and SharePoint
• Fluency in English (written and verbal)
• Ability to work flexible hours to accommodate German time zones
• Experience working closely with teams in Germany and aligning with CET/CEST working hours

Preferred Experience/Skills:

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

Quality Systems Specialist Overview:

This position is ideal for a detail-oriented professional with strong technical writing skills and a deep understanding of how quality system processes interact (e.g., change control, document control, training, and records management).

Quality Systems Specialist Job Duties:

• 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 (e.g., documentation updates, training completion, 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
• Support quality system integration and harmonization activities in a regulated environment
• Maintain compliance while driving effective change management across the organization

**Only those lawfully authorized to work in the designated country associated with the position will be considered.**

**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**