As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 50 years now. Today, worldwide more than 6,500 employees are working on this permanent challenge, at over 90 locations on all continents.
The Senior Systems Quality Engineer is responsible for all processes and procedures affecting production for Bruker Daltonik GmbH to ensure compliance with quality and regulatory requirements (including FDA 21 CFR 820, ISO 13485, ISO 9001, and IVDD / IVDR). To be successful, this position requires close collaboration with all functional department personnel to manage improvement plans, implementation, and effectiveness checks. The ideal candidate is a self-motivated individual who thrives as part of a highly skilled technical team within a dynamic and fast-paced work environment and contributes effectively to a quality team at various sites within a global quality management system.
- Facilitate and manage validation activities.
- Conduct lean activity to improve processes and eliminate waste.
- Manage the Bremen site activities of the ISO 27000 (information security management) activities.
- Facilitate timely completion of corrective and preventive actions (i.e. revisions/changes to quality specifications, test methodologies, design specifications, risk management documents, and sampling plans).
- Apply methodical problem-solving to identify issues or potential issues; implementing methods to capture the appropriate metric data; and applying appropriate statistical analysis method(s) for effective corrective and/or preventive actions.
- Implement methods to capture appropriate metric data applying the appropriate statistical analysis method(s) metrics as required.
- Reports to EVP CALID Quality, and works effectively within a quality team at various sites within a global quality management system.
- Perform other duties as required.
- B.S. / B.A. in a scientific or technical discipline.
- 5+ years of previous experience in a quality engineer position or quality management position in a regulated environment with a B.S. / B.A. or experience.
- Possesses working knowledge of FDA QSR, ISO 9001, ISO 13485, ISO 27000
- Competency in investigation and root cause analysis.
- Familiar with Risk Management (ISO 14971).
- Familiar with comparative Statistical Techniques, Sampling Plans.
- Excellent verbal, written, telephone, and interpersonal communication, presentation, and organizational skills, including ability to interface with multiple levels and affiliates.
- Fluent in German and English.
- Lead internal auditor.
- Effective project/program manager.
- Possesses working knowledge of lean (e.g., Kaizen blitzes, 5s) and/or transactional Six Sigma
- Previous experience working in a cross-functional team environment.
- ASQ CQE certification.
- Familiar with statistical software tools such as (Minitab, Stat Graphics, Statistica or Jump).
- Familiar with software tools such as SAP and quality management tools, such as, e.g., GrandAvenue, Master Control, …