Senior Quality Engineer Role
The Senior Quality Engineer will be responsible for ensuring that all products manufactured meet customer requirements. This includes integration and maintenance of the quality management system, as well as provision of support to all departments.
In this role, you will:
* Ensure that product introductions and change controls are effectively managed in accordance with regulatory requirements;
* Review and release batch paperwork for product release;
* Participate in new product introduction programs to ensure effective introduction;
* Generate product technical files and associated studies when required;
* Maintain customer complaint investigation processes and assist with product recalls and corrective/preventive action programs;
* Participate in routine failure investigation and process trouble-shooting;
* Maintain plant trending and continuous process improvement programs;
* Coordinate and maintain calibration and validation programs;
* Maintain plant environmental and cleaning/housekeeping programs, including sub-contractor maintenance;
* Ensure quality system and product requirements are included in training programs and adhere to plant safety and health and safety requirements;
Requirements include:
* 2-3 years' experience as Quality/Validation Engineer in Medical Device/Pharmaceutical environment;
* Third level qualification in Engineering/M Manufacturing/Quality with emphasis on Medical Device/Biomedical;
* Minimum Bachelor's degree in a Science/Engineering/Quality related discipline;
Benefits include:
* Competitive salary;
* Bonus;
* Pension and healthcare;
This is an excellent opportunity for a skilled Quality Engineer to take on a senior role and make a significant impact in our organization.