Bruker Corporation

Director, Quality Management Systems (m/w/d)

Arbeitsort DE-BW-Nehren
Datum der Veröffentlichung 6 days ago(1/11/2022 12:47 PM)
Antrags-Nr.:
2021-11451
Anzahl offener Funktionen
1
Positionstyp
Employee
Full Time/Part Time
Full Time

Überblick

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. As one of the world’s leading analytical instrumentation companies, Bruker develops high-performance scientific instruments and high-value 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 7,200 employees are working on this permanent challenge at over 70 locations on all continents.

 

Hain Lifescience GmbH is a manufacturer and distributor of in vitro diagnostics. Our customers include medical laboratories worldwide. Our key competences are molecular genetic test systems and devices for the detection of dangerous pathogens or hereditary diseases. Since October 2018, Hain Lifescience has been part of the globally successful technology group Bruker, which is headquartered in the USA.

 

The Director Quality Management Systems is responsible for developing, implementing and maintaining all applicable systems and processes that ensure the quality, reliability, and regulatory compliance of products and services. This applies to all activities of Hain Lifescience GmbH.

 

Aufgaben/Verantwortlichkeiten

  • Direct supervision of all employees of the quality department in Nehren. Indirect supervision of all relevant activities in all other departments

  • Develop, implement and maintain systems to meet all applicable external standards relating to Hain Lifescience GmbH’s activities and products.  These standards include, but are not limited to, ISO 13485, ISO 14971, IVDD / IVDR, FDA QSR, FDA cGMP, MEDDEV, UL, and CSA
  • Act as person responsible for regulatory compliance (PRRC) according to IVDR Article 15.3 (a), (c), and (d), and as management representative according to 21 CFR 820.20 (c) (3). Manage relationship with notified body
  • 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
  • Plan and manage departmental activities in accordance with agreed budgets and schedules
  • Report regularly to senior management
  • Participate in, and contribute to, the divisional quality management teams in other sites of BDAL and CALID
  • Closely work together with the Manager of Regulatory Affairs, who is responsible to manage regulatory approvals for medical devices / IVDs in all countries where Hain is active, and acts as PRRC according to IVDR Article 15.3 (b) and (e)

Qualifikationen

  • Bachelor's degree in engineering or a specific scientific field, or demonstrably equivalent training and experience
  • Demonstrated, successful multi-year work experience in managing a quality team
  • In-depth knowledge of ISO 9001, ISO 13485, ISO 14971, IVDD / IVDR, MEDDEV
  • In-depth knowledge of FDA QSR, FDA cGMP helpful
  • Office, and quality specific tools (e.g., GAS, DHC, Master Control, MiniTab,...) to achieve the objectives
  • Lead auditor training, PRRC trainings helpful               
  • Excellent written and verbal communication skills across the entire organization
  • Fluent in German and English
  • Some background in statistics is essential

Optionen

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