Company Overview
At Hamilton Bonaduz AG, we remain true to our vision - "We drive innovation to improve people's lives." Since 1950, the Hamilton companies have been dedicated to providing groundbreaking solutions for the health sector. As an innovative pioneer, we specialize in ventilators, automated pipetting, sample management, and the development of process sensors.
About the Business Unit Robotics
The Business Unit Robotics designs, produces, and distributes pipetting robots that automate liquid handling processes for a diverse range of customers, including those in the pharmaceutical and food industries, as well as in cell and DNA research.
How You Can Make a Difference
As Head of Quality and Regulatory Affairs, you will be an experienced leader tasked with guiding our transforming organization and teams in Quality Assurance, Regulatory Affairs, and Validation & Verification. Acting as a business and sparring partner for the Robotics Management Team, R&D, and the Commercial organization, your role will be pivotal.
Your main responsibilities will include:
- Ensuring quality assurance and compliance within the Business Unit while maintaining product and process conformity with all relevant standards. You will also be responsible for conducting internal audits.
- Strengthening and promoting quality awareness within the Business Unit and advising colleagues on quality-related and regulatory requirements.
- Developing and executing regulatory affairs strategies for global registrations, with a particular focus on the EU and Asia, including IVDR, Machine Directive, and GxP. You will closely collaborate with the Quality Management team of Hamilton Company in Reno, USA, for FDA registrations.
- Defining and overseeing standardization and implementation of systems/processes/communications to monitor the regulatory environment for changes that might impact our business products and goals, in coordination with cross-functional partners.
- Supporting all business segment initiatives identified by Corporate QA management, such as the Quality Management System (QMS), monitoring the CAPA process, and adhering to other regulatory requirements.
- Collaborating closely with R&D departments, Product Management, Operations, and the commercial organization to provide early indicators of the impacts of changes in regulatory and quality requirements.
- Managing the budget and resource planning within your department.
- Contributing to the continuous development of the Business Unit Robotics, including its strategy, structure, goals, and processes.
What You Bring Along
- A degree in natural sciences or engineering, complemented by several years of professional experience in Regulatory Affairs and Quality Management in 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, with over 10 years in design and development activities, verification and validation, and achieving IVDR, MDR, or GMP-compliant products.
- Familiarity with relevant quality management tools, systems, and methods.
- A strong understanding of the impact of culture, processes, and initiatives on quality.
- Profound knowledge and experience with regulations and major QM standards, including ISO 13485, ISO 9001, FDA 21 CFR Part 11, GMP, GAMP, IVDR, and 2006/42/EG.
- A comprehensive understanding of design control and risk management requirements through experience in design and development activities.
- Experience in leadership, change management, and project management, enabling you to motivate and engage your organization towards common goals.
- An ability to adopt pragmatic approaches that streamline key processes.
- Proficiency in English and German, along with exceptional communication and negotiation skills.
Join Our Team
Are you interested in being part of a cooperative and down-to-earth environment that values your skills and fosters innovative ideas? At Hamilton, we offer a motivating working atmosphere along with various leisure activities and modern working conditions. Our culture encourages open communication and collaboration among team members.
If you share our values and are ready to contribute to our team, apply online using the form below. Please note that only applications matching the job profile will be considered. If you have any questions, feel free to contact us at jobs@hamilton.ch, referencing JR-5004-fjb and contacting Susanne Berndonner. Applications submitted via post or email will not be considered.