How you can make a difference:
- Maintain and continuously improve the company’s Quality Management System in accordance with ISO 13485, FDA QMSR, EU MDR, MDSAP, and other applicable regulations.
- Ensure alignment of quality system processes with business objectives and regulatory expectations.
- Monitor regulatory changes and assess impacts on the QMS.
- Drive harmonization and standardization of quality processes across sites in Switzerland, Romania and USA.
- Audit and Inspection Management
- Lead internal audit programs and ensure compliance with audit schedules.
- Coordinate external audits conducted by Notified Bodies, regulatory authorities, MDSAP Auditing Organizations, and customers.
- Serve as a key representative during inspections and audits.
- Ensure timely resolution of audit findings and effectiveness of corrective actions.
- Compliance and Regulatory Support
- Partner with R&D, Regulatory Affairs, Manufacturing, Engineering, Service, and Operations to ensure ongoing compliance.
- Support product registrations and submissions through provision of QMS-related documentation.
- Ensure inspection readiness across all functions.
- Support regulatory agency interactions as required.
That’s what you bring along:
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related discipline.
- Master’s degree preferred.
- Minimum 8–10 years of experience in Quality Management Systems within the medical device industry.
- Minimum 3–5 years of leadership experience
- Experience supporting regulatory inspections and third-party audits.
- Experience within a global, highly regulated manufacturing environment preferred.
How to apply:
Learn more about career opportunities at Hamilton at Jobs | Hamilton Medical.
Do you share our values and feel at home in a cooperative, innovative, and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also purposeful work 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 [email protected] with the following details:
Applications by post or e-mail can unfortunately not be considered.
Skills Required
- Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related discipline
- Master's degree
- 8-10 years of experience in Quality Management Systems within the medical device industry
- 3-5 years of leadership experience
- Experience supporting regulatory inspections and third-party audits
- Experience in a global, highly regulated manufacturing environment
What We Do
Hamilton Company is a global manufacturer of precision measurement devices and scientific instruments for liquid handling, process analytics, robotics, and automated storage. Its products support researchers and professionals across life-science, laboratory, clinical, biopharmaceutical, manufacturing, and related markets. The company designs and makes products in facilities in the United States, Switzerland, and Romania, delivering engineered solutions that accelerate analysis and streamline scientific workflows.
