Quality Engineer (f/m/d)

☞ Straumann Group

View: 152

Update day: 26-03-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Information Technology Services Medical Devices Computer Software

Position: Entry level

Job type: Full-time

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Job content

Company Description

#ChangeMakers
Ready to make an impact?

We develop, manufacture and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others
We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

#WeChangeDentistry every day. Be part of it.

Job Description

The Quality Engineer ensures the appropriate standards/guidelines are in place for the validation program in order to support the design, validation and validation maintenance of facilities, equipment, systems, methods and processes.
  • Perform activities such as investigating non-conformances, performing corrective actions, gage R&R data collection and analysis,
  • Support continuous improvement activities
  • Directing validation approach and strategy to ensure continuous improvement consistent with established and evolving regulatory requirements and company requirements
  • Support qualification / validation efforts as defined in Validation Master Plan or adhoc support;
  • Coordinate with RA&C teams overview of product and system changes to be notified to Notified Body. Prepare / Review NoC (Notice of change) and be the liaison with Notify Body and assigned reviewers. Follow up on questions until approval of the change
  • Support for Notified Body audit coordination for new certification, surveillance and addition of new technology

Qualifications
  • University Degree (natural science or engineering)
  • Minimum of 5 to 7 years of experience in Quality in Medical Device Industry
  • Expert knowledge of ISO13485, MDD 93/42 EEC, EU Medical Device Regulation
  • Experience with preparing and managing internal/external audits
  • excellent stakeholder management skills
  • Ability to work in cross-functional, cross-culture teams
  • Proactive problem solving approach
  • business fluent English; German and French would be an advantage
Additional Information

This position reports to the Head of RA SDIS & RA Project Office and is based at the Corporate Headquarters in Basel, Switzerland.

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!
Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.

i-p-r

Summary
  • Type: Full-time
  • Function: Quality Assurance
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Deadline: 10-05-2024

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