Quality Manager

vor 2 Wochen

Home Office, Schweiz Bruker Vollzeit

Ãberblick:
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 60 years now. Today, worldwide more than 7,200 employees are working on this permanent challenge, at over 70 locations on all continents.

Aufgaben/Verantwortlichkeiten:

- Develop, implement and maintain systems to meet all applicable external standards relating to the Tämperlistrasse 8 activities and products. These standards include, but are not limited to, ISO 9001, ISO 13485, ISO 14971, IVDD / IVDR, FDA QSR, FDA cGMP, MEDDEV, UL, and CSA. Some in this list may not be applicable yet (e.g., FDA QSR, FDA cGMP, IVDD / IVDR) but may be in the future.
- Act as management representative for the above mentioned systems. Manage relationship with notified body, as applicable.
- Develop and maintain systems to measure performance against applicable quality and regulatory standards, and take necessary action to communicate, advise, and / or assist according to performance levels.
- Establish and implement necessary communication strategy for the improvement and awareness of quality and regulatory issues across all departments.
- Put special focus on supplier management and supplier quality
- Report regularly to senior management.
- Participate in, and contribute to, the divisional quality management teams in other sites of CALID (these teams will also support this role as applicable). Also, manage relationship to the other sites of Bruker Switzerland AG.

Qualifikationen:

- Bachelor's degree in engineering or a specific scientific field, or demonstrably equivalent training and experience
- A background in statistics is essential
- Multi-year work experience in a regulated environment (e.g., ISO 9001, ISO 13485, 21 CFR 820).
- In-depth knowledge of ISO 9001, ISO 13485.
- In-depth knowledge of FDA QSR, FDA cGMP, ISO 14971, IVDR, MEDDEV, MDCG helpful.
- Excellent written and verbal communication skills across the entire organization.
- Ability to work efficiently and effectively in a multi-site organization.
- Fluent in German and English.

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