QRC Manager (m/f/d)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. 

Are you looking for an inspiring career? You just found it.

Be part of Getinge as a

QRC Manager (m/f/d) 

Your responsibilities

• Responsible for ensuring the implementation and continuous maintenance of the Quality Management System (QMS) of the Swiss Sales & Service Unit in alignment with the Global Sales QMS
• Ensures full compliance with Swiss medical device regulations, including CH-REP and Swiss Importer requirements
• Acts as the key Quality contact for internal stakeholders, authorities, and external partners

Job Responsibilities and Essential Duties

Swiss Regulatory Compliance (Primary Focus)

• Ensure compliance with Swiss medical device regulations, particularly for CH-REP and Swiss Importer roles
• Maintain and control CH-REP and Importer documentation and registers
• Act as the primary contact for Swiss authorities (e.g., Swissmedic) and external bodies
• Support vigilance activities, post-market surveillance, and field safety corrective actions in Switzerland
• Ensure regulatory alignment for products placed on the Swiss market

Quality Management System

• Maintain, implement, and continuously improve the QMS in accordance with ISO 13485 and ISO 9001 standards
• Ensure effective document, record, and change control within the Sales & Service Unit
• Support management reviews, quality objectives, and KPI tracking
• Ensure compliance of local processes (sales, service, logistics, installation, distribution) with QMS requirements

Audits & Compliance

• Prepare and support internal and external audits (ISO, corporate, regulatory)
• Act as the local Quality representative during audits and inspections
• Manage CAPAs, non-conformities, deviations, and risk-based improvement measures
• Follow up on audit findings and ensure timely and effective closure

Training & Quality Culture

• Coordinate and deliver quality and regulatory training for local employees
• Ensure employee competence and awareness regarding QMS and regulatory requirements
• Promote a strong quality and compliance culture within the organization

Interfaces & Collaboration

• Collaborate closely with Global Quality, Regulatory Affairs, Supply Chain, Service, and Sales
• Support quality-related topics with distributors, service partners, and suppliers
• Provide quality input for business decisions and operational changes

Your profile

Education

• Bachelor’s or Master’s degree in:
• Engineering
• Life Sciences
• Quality Management
• Regulatory Affairs
• or a related technical/scientific field

Experience

• Approximately 5 years of experience in Quality Management within the medical device industry
• Hands-on experience with ISO 13485 and ISO 9001
• Experience in Sales & Service, distribution, or importer environments is preferred
• Knowledge of Swiss medical device regulations and CH-REP / Importer roles is a strong advantage

Required Knowledge, Skills & Abilities

• Solid understanding of regulatory and quality requirements for medical devices
• Structured, detail-oriented, and solution-driven working style
• Ability to work independently and take ownership of quality topics
• Strong communication and stakeholder management skills
• Fluent in English; German is an advantage

• Travel requirements: approximately 10–30%

Our offer

• High-quality products in a life-saving environment
• Attractive conditions, 30 vacation days per year
• Trusted working hours and possibility of mobile working
• Modern workplace equipment
• JobRad and corporate benefits (employee discounts)
• Career opportunities in a well-known company
• Individual training and further education opportunities

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About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.