Hamilton Bonaduz AG
True to the vision - "We drive innovation to improve people's lives," Hamilton companies have been providing innovative solutions for the health sector since 1950. We are pioneers in the fields of ventilators, automated pipetting, sample management, and the development of process sensors.
About the Business Unit Robotics
The Business Unit Robotics develops, produces, and distributes pipetting robots for the automation of liquid handling processes catering to a wide range of customers, from the pharmaceutical and food industries to cell and DNA research.
Your Impact
The Head of Quality and Regulatory Affairs is an experienced leader responsible for guiding a transformative organization and teams in Quality Assurance, Regulatory Affairs, and Validation & Verification. Acting as a business partner to the Robotics Management Team, R&D, and the Commercial organization, the Head of QA/RA plays a vital role in the following areas:
- Ensuring quality assurance and compliance within the Business Unit, aligning all products and processes with relevant standards and conducting internal audits.
- Strengthening and promoting quality awareness within the Business Unit and providing counsel on quality-related and regulatory requirements.
- Developing and executing regulatory affairs strategies for global registrations, particularly focusing on the EU and Asia (including IVDR, Machine Directive, GxP), and collaborating with Quality Management at Hamilton Company in Reno, USA for FDA registrations.
- Defining and overseeing the standardization and implementation of systems, processes, and communications to monitor the regulatory environment for changes impacting business products and objectives.
- Supporting all business segment initiatives identified by Corporate QA management, including the Quality Management System (QMS), monitoring the CAPA process, and other regulatory requirements.
- Collaborating closely with R&D departments, Product Management, Operations, and the commercial organization to provide early information about changes in regulatory and quality requirements.
- Managing budget and resource planning for the department.
- Contributing to the continuous development of the Business Unit Robotics, focusing on strategy, structure, goals, and processes.
Qualifications
- A degree in natural sciences or engineering combined with several years of professional experience in Regulatory Affairs and Quality Management within the GxP, IVD, or medical device industry; advanced business training is a plus.
- A minimum of 3-5 years of experience in RA/QA roles, totaling over 10 years dealing with design and development activities, verification, and validation to ensure IVDR, MDR, or GMP compliance.
- Familiarity with relevant quality management tools, systems, and methods.
- Understanding the impact of culture, processes, and initiatives on quality.
- Profound knowledge of regulations and major QM standards: ISO 13485, ISO 9001, FDA 21 CFR Part 11; GMP; GAMP; IVDR; 2006/42/EG.
- Understanding of design control and risk management requirements through experience in design and development, including commercialization.
- Leadership, change, and project management experience to develop and engage the organization toward common goals.
- A pragmatic approach to streamlining key processes.
- Proficiency in English and German, along with excellent communication and negotiation skills.
To learn more about career opportunities at Hamilton, visit jobs.hamilton.ch.
Do you share our values and thrive in a collaborative, down-to-earth environment? At Hamilton, we provide a motivating workplace, various leisure activities, and modern working conditions. Our emphasis on open communication fosters a pleasant working environment. Become part of a team that values your skills and nurtures innovative ideas. Interested? Then apply online using the form below. Please note that only applications matching the job profile will be considered.
If you have any questions, please contact us at jobs@hamilton.ch with the following details:
Reference: JR-5004-fjb / Contact: Susanne Berndonner