Leading a dynamic Quality Management System team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes. As Senior Quality Engineer, you will work closely with cross-functional teams to integrate and maintain our QMS in accordance with ISO 13485, MDD 93/42/EEC & MDR 2017/745 requirements.
The ideal candidate will have a strong background in quality engineering, preferably in a medical device or pharmaceutical environment. A degree in Engineering, Manufacturing, or Quality is essential, with emphasis on Medical Device or Biomedical disciplines.
Responsibilities include:
* Ensuring seamless integration of QMS with all Freudenberg Medical processes
* Providing support to departments to guarantee product manufactured meets customer requirements
* Effective management of product introductions and change controls in line with regulatory requirements
* Review and release of batch paperwork for product release
* Participation in new product introduction programs to ensure effective introduction in line with regulatory requirements
Additional responsibilities include:
* Maintenance of customer complaint investigation process and vigilance requirements
* Participation in routine failure investigations and process trouble-shooting
* Co-ordination and maintenance of calibration and validation programs
* Plant environmental and cleaning/housekeeping program maintenance
As Senior Quality Engineer, you will contribute to plant safety and health & safety requirements. Ensuring your work adheres to OH&S system standards, promoting a safe working environment for yourself and others.
Benefits include competitive salary, bonus, pension, and healthcare.
If you're passionate about delivering exceptional quality and driving business growth, this could be the perfect opportunity for you. Apply today to take your career to the next level!