Head of Quality Management, Campus Hennigsdorf (m/f/d)

Overview

Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker's high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research, in applied and biopharma applications, in microscopy and nanoanalysis, as well as in industrial and cleantech research, and next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics.

For more information, please visit www.bruker.com.

For our site in Hennigsdorf we are looking for a Head of Quality Management (m/f/d).

Responsibilities

The Head of Quality Management, Campus Hennigsdorf is responsible for the evolution, improvement, and maintenance of the global Quality Management System (QMS) necessary to ensure the highest quality, reliability, and regulatory compliance of products and services delivered. This applies to all activities At Campus Hennigsdorf, as well as to other QM-related activities of the CALID Group and the BMID division in particular.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Quality Leadership & Governance

• Act as quality management representative for Campus Hennigsdorf
• Establish and implement an effective communication strategy to strengthen quality and regulatory awareness across all departments while fostering and embedding a strong quality culture throughout the organization.
• Lead the QM team and provide leadership, coaching and personal development. Be a trusted partner to the management team.
• Oversee QMS governance, including Document Control, harmonization of QMS processes, and Management Review activities
• Ensure smooth integration and cooperation with other BMID or CALID sites, and participate in the development and strategy of the CALID Group QMS, of which the InVivo QMS is a part. Coordinate with the quality management in other BMID sites or sites of the Bruker CALID Group as needed.

Quality & Strategy & Planning

• Lead the integration of three subsidiaries into a unified Quality Management System
• Develop and implement a forwardlooking quality management strategy that actively aligns with the annual business plan and longterm company goals, including proactive resource planning, budgets, and schedules, and manage all departmental activities in accordance with these plans.

QMS Compliance

• Develop and maintain systems to meet external quality requirements relating to products and services. These requirements include: U.S. 21 CFR 820 (FDA QSR), ISO 9001, ISO 13485, ISO 14971, IVDR, and MDSAP, as applicable.
• Ensure efficient and effective compliance with these requirements in all parts of the organization, including research and development, production (in-house and outsourced), post-market surveillance, distribution and service /support.
• Monitor changes to external standards and regulatory requirements and integrate within internal quality management systems

Risk Management (ISO 14971)

• Maintain a compliant ISO14971 risk management process by overseeing lifecycle risk planning, analysis, and control for all IVD products, integrating risk management with design controls, usability engineering, postmarket surveillance, and complaint handling, and ensuring continuous review and maintenance of all risk management files.

• Access and manage quality-related business risks, including supplier disruptions, design issues, regulatory findings or manufacturing problems

Product & Production Quality

• Support of production controls and ensure compliant release of In Vitro Diagnostic and Research products. instruments, software and consumables / reagents according to appropriate regulations.
• Assure appropriate design controls for design changes and new product introduction according to appropriate regulations

Core Quality System Processes

• Oversee the management of the CAPA, Internal Audits, Supplier Quality processes.
• Oversee and manage the Non-Conformance (NC) process for product, process, material, and supplier deviations, ensuring timely investigation, root cause, documentation, and trend analysis.
• Establish/define/improve KPIs to measure performance against defined goals and requirements and take the necessary actions to ensure goals are met and continuously improved.

Lifecycle Monitoring & Continuous Improvement

• Oversee Post-Market Surveillance (PMS) activities, including complaint trending, field performance monitoring, and integration of PMS data into design and risk systems.
• Ensure vigilance reporting and timely communication of reportable events under IVDR.
• Ensure preparation and maintenance of PMS documentation, including PMS plans, PMS reports, PSUR, and PMPF support.

Supervisory Responsibilities

• Direct supervision of all employees of the quality department at the Campus Hennigsdorf (>15).
• Indirect supervision of all relevant personnel and activities in the organization, including the authority, to give directions on all qualityrelated matters.

Qualifications

Education and/or Experience:

• Master's degree in Life Sciences, Engineering, Quality Management, Regulatory Affairs(e.g., Biology, Chemistry, Biotechnology, Medical Technology, Industrial Engineering)
• Several years of leadership experience in Quality Management within the IVD, medical device or diagnostics.
• Deep understanding and multi-year experience in establishing, maintaining, and improving FDA QSR, ISO 13485, ISO 14971, ISO 9001, and IVDR Quality Management Systems.
• In-depth knowledge of design controls process, documentation management, change control, Corrective & Preventive action (CAPA), Nonconforming Product, product acceptance, product traceability, internal and supplier audits.
• Experience with quality strategies and resource planning.
• Experience of acting as a Quality Management Representative for audits and regulatory authorities

Computer Skills:

• MS Office, SAP (S4/HANA preferred) and electronic quality management tools (e.g., MasterControl) to achieve the objectives.

Certificates, Licenses, Registrations:

• Lead auditor certificate ISO 13485

Other Skills and Abilities

• Excellent written and verbal communications skills in German and English and across all levels of the entire organization.
• Experience with continuous improvement methodologies (e.g., Lean, Six Sigma preferred).
• Strong analytical mindset to interpret data, identify trends, and manage qualityrelated business risks.
• Ability to harmonize complex processes across multiple organizations and functions.

Personal Attributes

• Strong sense of ownership, responsibility, and integrity.
• High resilience and ability to manage complex, changing environments.
• Solutionoriented mindset with the ability to balance compliance and pragmatic execution.
• Collaborative, diplomatic, and able to build trust across different teams and sites.

Other Qualifications

• Engagement in professional networks (e.g., VDGH) is desirable to maintain external awareness and represent the company within the industry.