Quality Engineer– Development Medical Devices

Solothurnerstrasse 235, Switzerland | Olten | Full-time

Job Description

Interest in the development of complex (Electronic, Software and Mechanic) medical devices
Define and ensure compliance with quality requirements for drug delivery systems and medical devices in development projects
Design Control for Medical Devices is where you have your knowledge
Work as a lead with project manager topics for a small cross-functional team
Ensuring the conformity of our products and product documentation over the entire product life cycle – focus on development
Participation in risk analyses
Creation / Release of documents for design verification / design validation in Cross-Functional Team
Creation / Release of Test Plans / Test Setups / Design of Experiment
Review and release of changes to product design and manufacturing processes
Contact person for customers and suppliers with regard to product quality (incl. Measures such as NC, CAPA, SCAR, etc.)
Participation in the equipment qualification / process validation and evaluation of external production partners
Subject Matter Expert for quality-related questions in the context of audits by customers

Qualifications

A successfully completed engineering or scientific degree (mechanical engineering, physics or automation technology) or comparable qualification is desirable
At least three years of practical experience in design control for medical devices with Quality focus
Experienced in the FMEA method for medical devices
Practical experience in the application of quality and problem-solving techniques
Knowledge of the interpretation and implementation of regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485)
Experience in the field of software quality assurance desirable
Result-oriented, focused and structured way of working
Proactive, communicative and solution-oriented personality
Willingness and commitment to move things, ability to prioritize, planing and make decisions
Secure communication across all hierarchical levels as well as with customers and suppliers
Willingness to travel (ca. 10%)
English in spoken and written, German would be an advantage

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Benefits

Corporate Benefits

Benefit from special conditions with various brands in fashion, technology, leisure and many more.

Verpflegung

Je nach Standort gibt es bei uns frisches Obst, knusprige Snacks oder ein kleines Frühstück. Entweder haben wir eine Kantine im Gebäude oder bieten Verpflegungszuschüsse an. So bleiben Sie auch während der Pausen gesättigt und können voll durchstarten.

Gesundheits- und Vorsorgemanagement

Ihre Gesundheit und Ihr Wohlbefinden liegen uns am Herzen. Profitieren Sie daher von unseren vielfältigen Gesundheitsangeboten wie dem Betriebsarzt, der Gesundheitsvorsorge, jährlichen Check-ups, Fitnessangeboten, Stressprävention.

Fort- und Weiterbildungsangebote

Unser Fokus liegt auf der stetigen Weiterentwicklung unserer Mitarbeiter. Wir möchten sicherstellen, dass jeder Einzelne sein volles Potenzial ausschöpfen kann, und bieten daher passgenaue Trainingsangebote für unterschiedliche Positionen an. So verhelfen wir unseren Mitarbeitern zu maximaler Leistung und beflügeln ihren beruflichen Erfolg!

Mobile working

Unsere Mitarbeiter haben die Freiheit, ihre Arbeit zu verrichten, wo immer sie möchten. Mit unseren mobilen Arbeitsplatz-Optionen, Workation-Möglichkeiten und Home-Office-Lösungen können sie von jedem beliebigen Ort aus arbeiten. Volle Flexibilität ist bei uns Programm!

Working environment

Creating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).

Hinweis: Benefits können je nach Position variieren.

About Gerresheimer

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 12,000 employees and generated annual revenues in 2023 of around EUR 2bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Equal Rights

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. All applicants are considered without any regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status. Preference is given to hiring people with disabilities.

Interested? Apply today!

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