|Last Updated||2016-08-17 08:24:00|
|Location||DNK - Nordborg|
+41 (0) 78 674 70 53
Our client is an innovative and growing medical devices and equipment company with a location in Nordborg, Denmark
Due to the growth and success of our client we are now looking for a Quality Engineer to be a part of the Quality team in Denmark. The plant in Nordborg is our client's pilot manufacturing plant and the Quality Engineer will be responsible to take manufacturing capability to a new level for full scale-up.
This position will be based in Nordborg.
We are looking for a Quality Engineer with experience in completing verification and validation for in-line
manufacturing processes as well as product qualification tests. This position will offer the opportunity to
participate in the development of highly specialized equipment in a close team-work environment with
engineers, physicist and technicians.
The Quality Engineer will be responsible for the qualification of production systems and to support ongoing
production and will assist in the development and implementation of the Quality Management System for
the production in Nordborg. Areas of specific responsibility include:
· Participate / lead validation and qualification of Capillary production and testing processes.
· Support the development and continuous improvement of Capillary Production including developing
process risk plans (pFMEA).
· Support and performed Quality Control activities; incoming inspection, in-process and final
· Participate in the Manufacturing Review Boards (MRB) activities.
· Working with key suppliers to establish qualified measurements, process quality planning and
· Perform manufacturing process audits.
Quality Systems Support
· Lead Document Control process for DK site and backup for Document Control for site in US.
· Provide training and awareness on Quality Systems and compliance requirements.
· Perform internal and supplier audits.
· Support the Quality team with improvement initiatives of the Quality Management System.
Background and qualifications
· 3+ years experience, in a regulated industry, prior medical device experience is preferred.
· Engineering experience and demonstrated use of Quality tools/methodologies.
· Knowledge of FDA, GMP, ISO 13485, and ISO 14971 (including FMEA method) are preferred.
· Solid communication and team-work skills.
· Self-driven individual with leadership skills, able to resolve quality-related issues in a timely and effective
· Experience with product and process development and improvement methodologies (e.g., Six Sigma and
· Understands specifications in drawings and blueprints. Translates product specifications into test and
· Understands and applies basic uses of statistics in the manufacturing environment including gage R&R,
sampling plans, design of experiments, process capability and SPC and used in technical report writing.
· Able to read and write fluently in English. Danish language skills are preferred.
A BS or MS in Engineering or related technical degree is required.