Director Quality Management mwd

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. As one of the worlds leading analytical instrumentation companies

Bruker develops highperformance scientific instruments and highvalue analytical and diagnostic solutions that enable scientists to explore life and materials at molecular cellular and microscopic levels.

We have been driving innovation in analytical instrumentation for 60 years and today Bruker continues to build upon its extensive range of products and solutions its broad base of installed systems

and a strong reputation among its customers. Worldwide more than 9700 employees are working on this permanent challenge at over 100 locations on all continents.

The Director Quality Management is responsible for the evolution and improvement of the Quality Management System (QMS) necessary to ensure the highest quality reliability

and regulatory compliance of products and services delivered. This applies to all activities of Bruker Daltonics GmbH & Co. KG as well as the global distribution and support activities.

• Direct supervision of all employees of the quality department in the Bruker Daltonics GmbH & Co. KG sites. Indirect supervision of all relevant personnel and activities in the organisation.

• Develop and implement quality management strategy and plans including resources systems schedules and budget to support and integrate within the annual business plan and longterm strategy.
• 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 IVDR and MDSAP.
• Ensure efficient and effective compliance with these requirements in all parts of the organization including research and development production (inhouse and outsourced) postmarket surveillance distribution and service /support.
• Support of production controls and release of In Vitro Diagnostic and Research instruments software and consumables according to appropriate regulations.
• Assure appropriate design controls for design changes and new product introduction according to appropriate regulations.
• Oversee the management of the Complaint CAPA Internal Audits Supplier Quality and PostMarket Surveillance / Vigilance processes.
• Develop and maintain systems to measure performance against established goals and requirements.
• Monitor performance (in relevant areas) according to established goals and requirements and take necessary action to communicate/advise/assist according to performance levels.
• Monitor changes to external standards and regulatory requirements and integrate within internal quality management systems.
• Establish and implement necessary communication strategy for the improvement and awareness of quality and regulatory issues across all departments.
• Plan and manage departmental activities in accordance with agreed budgets and schedules.
• Report as necessary to senior management on changes in standards (internally and externally initiated) and on performance against standards.
• Coordinate with the quality management in other sites of the Bruker CALID Group as needed.

• Bachelors degree in engineering or a specific scientific field or demonstrably equivalent training and experience
• Demonstrated successful multiyear work experience in managing a quality team

• Demonstrated multiyear FDA QSR ISO 13485 ISO 9001 and IVDR compliance responsibility and experience as well as experience in managing a quality team.

• Indepth knowledge of design controls process documentation management change control Corrective & Preventive action (CAPA) product complaints MDR reporting Nonconforming Product and internal and supplier audits.

• 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;ASQ Quality Engineer Certificate desirable

• Other Skills and Abilities: Some background in statistics is essential.

  Six Sigma Green Belt or higher preferred

  Proficiency in lean methodology and tools desirable

  Excellent written and verbal communication skills across the entire organization.