Quality Engineer
Objective of the job
The Quality Engineer has the overall responsibility to manage, maintain and improve the OrbusNeich Quality Management System at the Hoevelaken site.
Major tasks
In cooperation with OrbusNeich facilities in the US and China the Quality Engineer will improve company processes, research regulatory requirements and coordinate changes to create and maintain an effective Quality Management System which complies with customer, business and regulatory requirements.
Ensures non-conformances corrections and corrective and/or preventive actions are implemented in a timely manner and responsible for completing all associated documentation.
Compiles metric data for metric review meetings and dashboards including CAPA meeting and Management Review.
Uses available reporting methods to identify opportunities for yield improvements and process or products corrective actions.
Create and implement internal quality audit plan and ensure audits are conducted according to plan.
Participate in conducting supplier audits.
Responsible for coordination of employee training and maintaining training records.
Participate in new product development projects, create and implement product quality plans and ensure that device design is correctly translated into production specifications.
Lead global process improvement projects and promote the use of statistical tools (i.e. Six Sigma) to accomplish product and process improvement goals.
Back up for QA production support, e.g. receiving inspection and final release of products.
Performs other related duties and assignments as required.
Back up for the Quality Manager.
Requested profile
Education level of College degree (in technical / business processes).
Experience with Medical or Pharmaceutical industry, FDA QSR and ISO13485 is preferred.
Experience in similar type of role for at least 5 years.
Monitoring experience of Quality Systems, products and documenting results.
Capable of implementing statistical methods for process controls.
Excellent communication skills.
Pro active and focus on Quality.
Excellent knowledge of Dutch and English language (verbally and written).
Able to build relationships across work groups and organizations; coaches (external) teams to achieve high performance and self-managing capability; maintains close relationships across organizational boundaries to achieve business results; recognizes diverse stakeholder needs and gains support for shared organizational goals.
Demonstrates a deep-seated need for achievement and excellence; consistently exceeds expectations; perseveres; balances need for power with strong need for accomplishment.
Behaves with openness and predictability; maintains consistency between words and actions; consistent values.
Resilient to stress; keeps a realistic, but optimistic outlook for the future when faced by adversity; accepts the consequences of difficult decisions; learns from mistakes.
We offer
An interesting and challenging job in an international working environment.
In case you are interested in this position, please forward complete résumé, before August 15th, in English to the HR Manager Rian Ratgers at
rratgers@OrbusNeich.com.
