Quality Manager (m/f/d)

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Thun, Bern, CHE
In-Office
Senior level
Biotech
The Role
The Quality Manager develops and maintains quality and regulatory systems, ensuring product, service, and operational compliance. Responsibilities include managing ISO 9001 and related standards, coordinating audits and certification bodies, overseeing supplier quality, corrective actions, reporting, continuous improvement, and information security controls aligned with ISO 27001. The role also provides limited workplace safety support. The position requires quality management expertise, regulated-environment experience, German and English fluency, QMS and SAP proficiency, and knowledge of relevant ISO standards.
Summary Generated by Built In
Überblick

TOFWERK, a Bruker company, is making the world a cleaner place through innovative solutions for chemical analysis.


Our scientists and engineers develop, manufacture, and optimize high-performance mass spectrometers for new applications, supporting researchers and industrial customers around the world.

We are headquartered in Thun, Switzerland, with regional offices in China, the USA, Japan, and Korea. Within our team, we foster a collaborative and creative working environment. Together, we deliver products and services of the highest quality to ensure the success of our customers.


For more information, please visit: www.bruker.com and www.tofwerk.com


To strengthen our team, we are looking for a Quality Manager (m/f/d). We offer an exciting opportunity to join an innovative high-tech company in an international environment.The position is based in Thun, Switzerland.

Aufgaben/Verantwortlichkeiten

The job holder develops, implements, and maintains the quality and regulatory systems and processes required to ensure the quality, reliability, and compliance of Tofwerk AG products, services, and activities. The role also contributes 5–10% of working time to workplace safety by providing specialist support and coordination; it does not hold sole responsibility for EHS or workplace safety.

Quality and EHS responsibilities

  • Develop, implement, and maintain systems that meet applicable quality and regulatory standards, including ISO 9001 and, where applicable, UL, and CSA.
  • Act as management representative for applicable quality systems and manage relationships with certification bodies, notified bodies, auditors, and authorities as required.
  • Establish performance monitoring, reporting, and corrective action mechanisms for quality, regulatory, and information security requirements (if needed).
  • Drive quality awareness and continuous improvement across departments, with particular focus on supplier management and supplier quality.
  • Report regularly to senior management and collaborate with quality and information security teams across BIOS and Bruker sites.
  • Develop and maintain policies, procedures, controls, and assessment mechanisms supporting ISO 27001 and related information security frameworks.
  • Participate in, and contribute to, the divisional quality management teams in other sites of BIOS (these teams will also support this role as applicable). Also, manage relationship to the other sites of Bruker Corporate.
  • Provide workplace safety support for 5–10% of working time, including assistance with safety programs, employee information, improvement proposals, and coordination between BIOS and Tofwerk.

EHS activities are performed in a supporting and coordinating capacity; overall and sole responsibility remains with the designated responsible management and EHS functions.

Qualifikationen
  • Quality Management Diplom/ Master’s degree
  • additional qualifications: 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, ISO 9001, ISO 13485)
  • Fluent verbal and written communication skills in English and German (min. C1 Level) are required for this role.
  • Work Safe Assistant or higher quantification according to Switzerland regulations
  • QMS Software Expert
  • SAP Modul (Expert)
  • MS Office

Skills Required

  • Quality Management Diploma or Master's degree
  • 5+ years of experience in quality engineering or quality management in a regulated environment
  • Working knowledge of ISO 9001 and ISO 13485
  • Fluent written and verbal English and German communication skills, minimum C1 level
  • Work Safe Assistant qualification or higher under Swiss regulations
  • QMS software expertise
  • SAP module expertise
  • Microsoft Office proficiency
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The Company
HQ: Billerica, MA
3,346 Employees
Year Founded: 1960

What We Do

Right from the beginning, which is now more than fifty years ago, Bruker has been driven by a single idea: to provide the best technological solution for each analytical task. Today, worldwide, more than 6,500 employees in over 90 locations on all continents are focusing their efforts on this permanent challenge. Bruker systems cover a broad spectrum of applications in all fields of research and development and are used in all industrial production processes for the purpose of ensuring quality and process reliability.

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