Ingénieur qualité

TN Switzerland; Villeret; Vor Ort; CHF 80’000 - 110’000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der Medizintechnik sucht einen Qualitätsingenieur, der für die Einhaltung von Standards und Vorschriften verantwortlich ist. In dieser spannenden Rolle werden Sie an der Einführung neuer Produkte mitwirken und Qualitätsuntersuchungen durchführen, um kontinuierliche Verbesserungen zu fördern. Sie arbeiten eng mit verschiedenen Teams zusammen, um potenzielle Risiken zu identifizieren und Lösungen zu präsentieren. Wenn Sie eine Leidenschaft für Qualität und Innovation haben, ist dies die perfekte Gelegenheit für Sie, in einem dynamischen Umfeld zu arbeiten und einen echten Unterschied zu machen.

Qualifikationen

• Mindestens 5 Jahre Erfahrung in der Medizintechnik oder Pharmaindustrie.
• Erhebliche Erfahrung in der Prozessvalidierung und Gerätequalifizierung.

Aufgaben

• Verantwortung für die Einhaltung des Qualitätsmanagementsystems.
• Erstellung und Überprüfung von Validierungsberichten und Änderungsanfragen.

Kenntnisse

Qualitätsmanagement

Risikomanagement

Statistische Prozesskontrolle

Projektmanagement

Kommunikationsfähigkeiten

Detailgenauigkeit

Englisch

Französisch

Ausbildung

Ingenieurabschluss oder gleichwertig

Tools

Six Sigma

Jobbeschreibung

We are looking for a Quality Engineer (m/f/x) to join our Quality department at Straumann Villeret SA, the main dental implant system production site of the Straumann Group. Located in the French speaking part of Switzerland our production sites in Villeret and Corgémont currently employ more than 1,000 staff.

In your role you will…

• Be responsible for all aspects of compliance within the quality assurance system for the designated sector.
• Ensure that products are manufactured in accordance with standards and regulations applicable to Medical Device Manufacturing.
• Be responsible for creating, reviewing, and releasing validation reports, change requests, risk management reports, NCR, CAPA and complaint investigations.
• Actively participate in new products introduction.
• Apply risk management to all applicable processes and activities of Straumann Villeret SA.
• Ensure that all process / equipment validations are carried out prior to use in production.
• Lead or support capacity increase projects (automation, new equipment introduction, etc…)
• Use statistical analysis of quality data to reduce the costs of non-quality.
• Work with the Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.
• Closely collaborate with production and other relevant sectors to proactively identify potential risks in the assigned area, install a culture of problem solving and continuous improvement.
• Act as an SME during internal and external audits.

We are looking for …

• Engineering degree or equivalent.
• At least 5 years experience in the medical device or pharmaceutical industry.
• Significant experience in process validation and equipment qualification.
• Demonstrated technical understanding of manufacturing processes (machining, device cleaning, surface treatment, statistical process control, automated process control).
• Six Sigma Green or Black belt preferred.
• Thorough understanding of norms and standards applicable to the medical device industry including ISO13485 and 21CFR part820 required.
• Great communication and project management skills, able to prioritize effectively and meet deadlines.
• Rigorous with attention to detail.
• Fluent in English and French.

Additional information

Activity rate: 100%

Starting date: ASAP / to be discussed.

Contract type: CDI.

Place of work: Villeret.

What can you expect from us?

An agile and ambitious environment: We are #ChangeMakers.

Open, friendly colleagues who collaborate and support each other: We are #Players+Learners.

The freedom to create and engage in an environment with the opportunity to develop yourself as a person and in your career.

To work for the No. 1 in Dentistry and one of the leading MedTech companies.

And many other things!

The Straumann Group is proud to be an equal opportunities organization. We truly value diversity in all its forms recognizing that to truly deliver value to our patients, we must reflect our patient diversity in our internal workforce. Together we are creating smiles and restoring confidence.

#WeChangeDentistry every day – and we want you to be a part of it!