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QRC Manager (m/f/d)

Getinge Schweiz AG -
Rheinfelden, AG

Jetzt bewerben

Details zur Stelle

vor 8 Tagen

Leistungen

Mitarbeiterrabatt
Unterkunft

Qualifikationen

Management-Erfahrung
Vertrieb
Englisch
Master
Bachelor
Kommunikationsfähigkeit
ISO 13485
Deutsch

Vollständige Stellenbeschreibung

QRC Manager (m/f/d)

Date: May 26, 2026

Location: Rheinfelden, CH

Company: Getinge Schweiz AG

Remote Work: 3-4 days at home (hybrid)

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

#LI-KS2

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.

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