QRC Manager (Medical Devices)

TL;DR

QRC Manager (Medical Devices): Ensuring the implementation and maintenance of the Quality Management System (QMS) and regulatory compliance for the Swiss Sales & Service Unit with an accent on Swiss medical device regulations and ISO standards. Focus on maintaining CH-REP and Importer documentation, managing audits, and ensuring full alignment with Swissmedic requirements.

Location: Rheinfelden, Switzerland (Hybrid: 3-4 days at home)

Company

hirify.global is a global provider of life-saving technology and solutions for intensive care, cardiovascular procedures, operating rooms, and life science institutions.

What you will do

• Implement and maintain the Quality Management System (QMS) in alignment with Global Sales standards and ISO 13485/9001.
• Ensure full compliance with Swiss medical device regulations, focusing on CH-REP and Swiss Importer requirements.
• Act as the primary contact for Swiss authorities (e.g., Swissmedic) and external partners regarding quality and regulatory matters.
• Manage internal and external audits, CAPAs, non-conformities, and risk-based improvement measures.
• Coordinate and deliver quality and regulatory training to local employees to promote a strong compliance culture.
• Collaborate with Global Quality, Regulatory Affairs, Supply Chain, Service, and Sales teams.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality Management, or Regulatory Affairs.
• Approximately 5 years of experience in Quality Management within the medical device industry.
• Hands-on experience with ISO 13485 and ISO 9001 standards.
• Knowledge of Swiss medical device regulations and CH-REP / Importer roles.
• Fluent English proficiency; German is a strong advantage.
• Must be based in or able to work in Rheinfelden, Switzerland.

Nice to have

• Experience in Sales & Service, distribution, or importer environments.

Culture & Benefits

• 30 vacation days per year.
• Flexible work arrangement with the possibility of mobile working (3-4 days at home).
• Modern workplace equipment and corporate discounts.
• Individual training and further education opportunities.
• JobRad program.