Quality Systems Manager, BIOTRONIK Neuro

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As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.
We are seeking a Quality Systems Manager to support and maintain the Quality Management System (QMS) and ensure compliance with applicable medical device regulations and standards. This role is responsible for leading Quality Systems activities that support internal quality systems, product quality and distribution.
The Quality Systems Manager will partner with cross-functional teams to ensure processes comply with regulatory requirements while driving continuous improvement initiatives throughout the organization. The successful candidate will provide technical leadership, foster collaboration, develop company capabilities, and contribute to achieving departmental and organizational quality objectives.
Essential Functions:
Manage Quality Systems activities in accordance with company policies and applicable regulations.
Serve as a primary point of contact for Quality Systems with internal stakeholders and support interactions with corporate quality, regulatory, operations and clinical organizations
Serve as point of contact for physician communications regarding returned product analysis test results.
Lead and support cross-functional teams to ensure product quality and distribution activities comply with applicable regulations, standards, and company procedures.
Implement, maintain, and continuously improve quality processes, procedures, and systems, including internal audit, change management, , supplier quality, clinical research quality, complaint handling, and document control processes.
Manage external contract design and manufacturing (CMDO) organizations in partnership with the sourcing organization
Monitor departmental goals, metrics, and performance indicators to ensure achievement of quality objectives.
Support resource planning and provide input into company and departmental budgets and staffing requirements.
Promote awareness of regulatory, quality, and customer requirements throughout the organization.
Identify and communicate potential quality and compliance risks and recommend appropriate actions.
Support maintenance and improvement of FDA 21 CFR Part 820 QMSR, ISO 13485, and other applicable quality system requirements across internal and external sites.
Lead internal and external audits and support inspections by regulatory agencies and notified bodies.
Drive continuous improvement initiatives related to quality systems processes, and compliance activities.
Required Education and Experience
Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences, or a related technical field. Advanced degree preferred.
5-10 years of experience in a medical device, pharmaceutical, or biomedical, quality environment.
Experience supporting quality engineering activities within a regulated product environment.
Strong understanding of risk management, supplier quality, complaint management, and quality systems requirements.
Ability to effectively communicate technical and regulatory requirements across multiple organizational levels.
Familiarity with configuration/change management practices.
Demonstrated ability to influence cross-functional stakeholders and manage competing priorities.
Strong analytical, organizational, and problem-solving skills.
Excellent written and verbal communication skills.
Specific Knowledge & Skills:
Working knowledge of FDA regulations, including 21 CFR Parts 11, 801, 803, 806, 807, 812, 820, 822, and 830
Working knowledge of ISO 13485 and quality management s

Employment type
Undefined