Job Title: Senior Quality Engineer
* Ensure conformity to ISO 13485, MDD 93/42/EEC & MDR 2017/745 in all processes.
* Support the Management Representative and provide guidance as needed.
* Collaborate with various departments to guarantee products meet customer specifications.
* Implement effective product introductions, change controls and batch paperwork release according to ISO 13485 requirements.
* Participate in new product introduction programs, generating Product Technical Files and associated studies as necessary.
* Maintain the Customer Complaint investigation process, assisting in product recalls and corrective action programs.
* Conduct routine Failure Investigation and process trouble-shooting.
* Develop and maintain plant trending and Continuous Process Improvement programs.
* Engage in the Plant Corrective Action Programme and Internal Quality Audit Programme.
* Coordinate Calibration and Validation programmes.
* Maintain plant environmental and housekeeping standards, including sub-contractor maintenance.
* Manage Laundry and Rodent Control Sub-Contractors to required standards.
* Liaise with vendors for assessment and maintenance purposes.
* Incorporate quality system and product requirements into training programs.