Quality Engineer

Join our QA Team! We bring out the best in people with our effort to make people smile. We are currently looking for several Quality Engineers in our Quality Assurance organizations, Dentsply Sirona. The Quality Engineers will be based in Mölndal Sweden.
The main objective for the position is to secure Quality Assurance for Products and Processes within DentsplySirona Implants. The Quality Engineer (QE) will work close with Manufacturing and either lead or take part in Improvement Projects.
As a QE you will work in a Global Environment and be part of a cross functional teams. Implementation of new way of working requires close cooperation with other functions either local or global. Close cooperation with other Manufacturing sites within the Dentsply Sirona organization.
Responsibilities:
Perform Process and System Improvements.
Facilitate root cause investigations for CAPA and NC Process.
When needed, lead and coordinate market actions when occur.
Perform QA review of Process Validation activities.
Actively be part in Design Transfer activities with QA knowledge.
Participate as QA representative in New Development Project.
Act as Internal Auditor according to audit plan.
External Audits, be part of preparation, execution and follow up.
Document Control, provide knowledge and support to the organisation.
Manage Calibration Process and secure compliance.
Support Manufacturing team with QA knowledge and guidance.
Perform Measurement System Analysis (MSA).


Who you are
For this role in a truly global business environment, we look for qualified candidates with a relevant background:
An academic degree in engineering or equivalent professional background
experience from working in the medical device industry and have knowledge about
ISO 13485, 21 CFR Part 820 and EU Medical Device Regulation 2017/745
experience from Product and Process Validations
trained in Six Sigma, Gauge R&R and MiniTab
knowledge in measurement techniques for medical device
excellent communication skills as the role requires close contact with several functions/sites
participation in and experience of Audits from external parties
good communication in English as well as Swedish, both written and verbally.


If you have worked as a Lead Auditor and/or have good knowledge in the statistical area this is an advantage.
We look for a colleague with analytical skills, attention to details and the ability to work both in cross functional team and independently. We believe that you are a positive and social person with the ability to maintain good relations with both external and internal contacts. It is an advantage if you have strong focus on and drive to achieve goals and targets. As you will be working in a global environment, your English must be excellent, written and spoken alike.


We look forward hearing from you, welcome with your application no later than October 8th. Please note that we will review applications continuously, so be sure to send in your application as soon as possible.