As a Senior Quality Engineer, you will be responsible for integrating and maintaining the quality management system with all processes in accordance with ISO 13485, MDD 93/42/EEC & MDR 2017/745.
Key Responsibilities
* Deputise for the Management Representative in their absence.
* Provide support to ensure products manufactured meet customer requirements.
* Ensure product introductions and change controls are effectively managed.
* Review and release batch paperwork for product release.
* Participate in new product introductions programs and generate product technical files.
* Maintain the customer complaint investigation process and assist with product recalls.
* Participate in routine failure investigations and process troubleshooting.
* Co-ordinate and maintain calibration and validation programs.
* Ensure quality system and product requirements are included in plant training programs.
Requirements
The ideal candidate will have:
* Excellent communication and interpersonal skills.
* A strong understanding of quality management systems and regulatory requirements.
* Proven problem-solving and analytical skills.
* Ability to work effectively in a team environment.
* Strong attention to detail and organizational skills.
Benefits
This role offers:
* Opportunity to work in a dynamic and growing company.
* Competitive salary and benefits package.
* Professional development and growth opportunities.