True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.The Business Unit Robotics develops, produces and distributes pipetting robots for the automation of liquid handling processes for a wide range of customers from the pharmaceutical and food industry, all the way to cell and DNA research.
How you can make a difference:
The Head Quality and Regulatory Affairs is an experienced leader to guide a transforming organisation and teams in Quality Assurance, Regulatory Affairs and Validation & Verification. The Head of QA/RA is acting as a business and sparring partner for the Robotics Management Team, R&D and Commercial organisation.
The main responsibilities comprise the development of Regulatory Intelligence, Quality Compliance and Quality Awareness, the internal education of key departments on the above items and the decisive contribution to enabling the market access of innovative, safe, and reliable technologies in the field of laboratory automation.
- You ensure quality assurance and compliance within the Business Unit as well as the conformity of products and processes within the Business Unit Robotics with all relevant standards and are responsible for internal audits
- You will strengthen and promote quality awareness within the Business Unit and advise your colleagues on quality-related and regulatory requirements
- You develop and execute regulatory affairs strategies for global registrations with special focus to EU and Asia (including IVDR, Machine Directive, GxP); for global strategies with focus to FDA registrations you will closely cooperate with Quality Management of Hamilton Company in Reno, USA
- With cross-functional partners, you will define and oversee the standardization and implementation of systems/processes/communications to monitor the regulatory environment for changes that may have an impact on business products and goals
- You support all business segment initiatives as identified by the Corporate QA management, e.g. the Quality Management System (QMS), monitoring of the CAPA process and other regulatory requirements
- You and your team work closely with the R&D departments, Product Management, Operations and the commercial organisation and provide early information about the effects of changes in the regulatory and quality requirements
- You are responsible for the budget and resource planning in your department
- You contribute to the continuous development of the Business Unit Robotics: strategy, structure, goals, and processes
That's what you bring along:
- You have a degree in natural sciences or engineering combined with several years of professional experience in Regulatory Affairs and Quality Management in the GxP, IVD, or medical device industry; ideally, you also have advanced business training
- You bring a minimum of 3-5 years' experience with RA/QA roles and overall 10+ years, dealing with design and development activities, verification and validation activities or other aspects to achieve an IVDR, MDR or GMP compliant product
- You are familiar with the relevant quality management tools, systems and methods
- You have experience and a very good understanding of why and how culture, processes and the right initiatives impact quality
- You have profound knowledge and experiences with regulations/major QM-Standards: ISO 13485, ISO 9001, FDA 21 CFR Part 11; GMP; GAMP; IVDR, 2006/42/EG
- You have a good understanding of design control and risk management requirements through experience in design and development activities including commercialization
- Your experience in leadership, change and project management will help you to develop and engage your organisation to reach for common goals
- You have a good feeling for pragmatic approaches that allow to streamline key processes
- You have very good English and German language skills as well as excellent communication and negotiation skills
Learn more about career opportunities at Hamilton at jobs.hamilton.ch.
Do you share our values and feel at home in a cooperative and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also various leisure activities and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered. Interested? Then apply online using the "Apply now" button.If you have any questions, please contact us at jobs@hamilton.ch with the following details:
Reference: JR-5004-fjb/Contact: Susanne Berndonner
Applications by post or e-mail can unfortunately not be considered.