Medical Device Quality Assurance Specialist

3 weeks ago


Walsall, Walsall, United Kingdom KaneHR Full time

Xstrahl, a leading medical technology company, is shaping the development of superficial and orthovoltage therapies for cancer treatment.

Job Overview

We are seeking a Quality Engineer to work with our production team in ensuring suppliers meet quality standards and requirements.

This role involves conducting supplier quality assessments, creating and following up on SCARs, and ensuring the Device History Record (DHR) is up-to-date.

The successful candidate will play a key role in maintaining document control, CAPA, and complaints processes effectively.

Main Responsibilities
  • Ensure suppliers adhere to quality standards specified in supplier quality agreements
  • Create and manage production feedback reports, NCRs, and CAPAs for product and process issues
  • Inspect incoming parts from suppliers to ensure they meet design specifications and quality requirements
  • Manage SCARs and follow up with suppliers to ensure corrective actions are effective
  • Review DHRs for completeness before authorizing shipment of products
  • Support the QARA team in CAPA, document control, and complaints processes
Requirements and Qualifications
  • Experience working in the medical device industry as a quality engineer is essential
  • Working knowledge of ISO 13485 and ISO 14971
  • Experience working with manufacturing/production in quality control
  • Knowledge of EU MDR transition processes is a plus but not mandatory
Benefits

This is a full-time, permanent role with a salary between £30,000-£35,000 depending on experience.



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