Continuous Improvement Quality Engineer

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Location Leiden, South Holland Salary competitive
Sector Engineering, Life Sciences Type contract


* Optimize systems and processes that are aligned with Mentor Medical System's strategy and mission effecting continuous quality improvement.


Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

* Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements.

* Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.

* Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.

* Responsible for pFMEA documentation and leading pFMEA meetings.

* Reviews validations documentation (eg. IQ, OQ, PQ and verification studies).

* Leads or is team member of CAPA investigation and action plans.

* Leads or is team member of Internal audit observation investigation and action plans.

* Investigate instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of product.

* Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations.

* Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures


* Bachelor's degree (B.S.) in engineering, science, mathematics or statistics is required.

* A minimum of three years related manufacturing experience and/or training; or equivalent combination of education and experience is desired;

* Demonstrated knowledge of good manufacturing principles and practices, and procedures;


- Able to work on cross-functional teams is required. Must also be able to communicate effectively within diverse interdepartmental groups.

- Six Sigma Blackbelt or Greenbelt certification preferred.

- Strong plus: experience in microbiology sterilisation